FDA Device Registration & Listing · Fort Worth, TX, US · Registration 1610287
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2024-09-12 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2024-09-12 |
| LPM | Lenses, Soft Contact, Extended Wear | Ophthalmic | Class 3 | 886.5925 | 2023-08-31 |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | Ophthalmic | Class 1 | 886.4300 | 2021-08-25 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2014-10-15 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2013-10-30 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2008-02-07 |
| QDW | Phaco Kit | Ophthalmic | Class 2 | 886.4670 | 2024-02-07 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2014-02-10 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2013-12-04 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2013-12-04 |
| LRX | Case, Contact Lens | Ophthalmic | Class 2 | 886.5928 | 2007-12-19 |
| LWL | Fluid, Intraocular | Ophthalmic | Class 3 | 886.4275 | 2008-06-10 |
| QDY | Vitrectomy Kit | Ophthalmic | Class 2 | 886.4150 | 2024-02-07 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2013-12-10 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2019-08-22 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2024-12-17 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2023-01-12 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2023-01-12 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2022-01-04 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2022-01-04 |
| PZG | Surgical Eye Tray | Ophthalmic | Class 1 | 886.4350 | 2024-02-07 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2023-01-12 |
| KYD | Strip, Schirmer | Ophthalmic | Class 1 | 886.1800 | 2004-02-03 |
| QDV | Iol Tray | Ophthalmic | Class 1 | 886.4350 | 2024-02-07 |
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | Ophthalmic | Class 2 | 886.5918 | 2015-01-27 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2015-01-27 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2017-11-14 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2017-11-14 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2019-04-04 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2019-04-04 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2012-07-24 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2012-02-10 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2013-08-13 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2013-08-13 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2019-01-09 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2019-01-09 |
| OJK | Eye Tray | Ophthalmic | Class 2 | 886.4790 | 2024-02-07 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2020-07-08 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2020-07-08 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Ophthalmic | Class 1 | 886.4750 | 2002-04-15 |
| MOE | Collagen Corneal Shield | Ophthalmic | Class 1 | 886.4750 | 2002-04-15 |
| ORZ | Eyelid Thermal Pulsation System | Ophthalmic | Class 2 | 886.5200 | 2020-09-18 |
| HMT | Drape, Patient, Ophthalmic | General, Plastic Surgery | Class 2 | 878.4370 | 2018-05-23 |
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | Class 2 | 886.5925 | 2023-01-12 |
| MVN | Lens, Contact, (Disposable) | Ophthalmic | Class 2 | 886.5925 | 2023-01-12 |
| LZP | Aid, Surgical, Viscoelastic | Ophthalmic | Class 3 | 886.4275 | 2014-10-15 |
| HNR | Forceps, Ophthalmic | Ophthalmic | Class 1 | 886.4350 | 2002-04-15 |
| LPN | Accessories, Soft Lens Products | Ophthalmic | Class 2 | 886.5928 | 2012-04-19 |
No official correspondent registered.
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013497605 | Alcon Research, LLC | Sinking Spring, PA, US |
| 3003701944 | OPTONOL, LTD | NEVE ILAN Central, IL |
| 3016232028 | LUMITHERA, INC. | Fort Worth, TX, US |
| 3006186389 | CIBA VISION JOHOR SDN.BHD., | GELANG PATAH, JOHOR DARUL TAKZIM, MY |
| 3016075957 | IVANTIS, INC. | Irvine, CA, US |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K191650 | Alcon Research, LLC | LEGION System | 2019-11-01 |
| K133079 | Alden Optical Labs., Inc. | IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) | 2013-12-17 |
| K941998 | Ocu-Ease Optical Products, Inc. | OCU-FLEX-38 (POLYMACON) | 1994-10-13 |
| K992500 | Cantor & Silver , Ltd. | CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS | 1999-08-18 |
| K984098 | Adventures IN Color Technology, Ltd. | ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS | 1999-05-10 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0304-2026 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000250 UNITY 27+DS HYPERVIT 30K VIT PROBE
8065753168 UNITY 25+ 7.5K ANTERIOR VIT PROBE
8065753179 UNITY 25+ HYPERVIT 30K VIT PROBE
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A |
| Z-0305-2026 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065750918 PAK,I/A LINE,NGVS
8065750957 ASSY,SHIP,CONSTELLATION VFC
8065750972 ENDOILLUMATOR,RFID,23G
8065751014 CONST AUTO GAS FILL PAK
8065751014 CONST AUTO GAS FILL PAK
8065751441 ENDOILLUMINATOR,RFID,25G
8065751577 CHANDELIER,25GA,W/RFID
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A |
| Z-0306-2026 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000393 UNITY HP VISCOUS FLUID CONTROL VFC PACK
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A |
| Z-0307-2026 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000252 UNITY 27 GA CHANDELIER
8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A |
| Z-0308-2026 | Alcon Research LLC | 1 | Brand Name: Alcon Laboratories, Inc.
Product Name: Accessory devices for Unity and Constellation surgical consoles
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT
8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT
8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT
8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD
8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD
Software Version: N/A
Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console.
Component: N/A |
| Z-0326-2026 | Alcon Research LLC | 2 | Alcon PRECISION1 One-Day Contact Lenses, -2.25D. |
| Z-0490-2025 | Alcon Research LLC | 2 | a) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11, containing TUBING, SALEM SUMP, 14 FR;
b) Alcon Custom-Pak DR GREEN VITRECTOMY MERCY HOSPITAL, # 6557-59 and # 6557-60 each containing TUBING, SALEM SUMP, 18 FR;
c) VITRECTOMY ILLINOIS MASONIC MED CTR, # 9456-59, # 9456-60, and # 9456-61 each containing TUBING, SALEM SUMP, 18 FR;
d) VITRECTOMY MCGEE EYE SURG CTR, # 12216-12, # 12216-14, and # 12216-15, each containing TUBING, SALEM SUMP, 14 FR. |
| Z-0581-2026 | Alcon Research LLC | 2 | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF:
25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093;
25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095;
27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096;
23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413;
25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415;
27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417;
TOTAL PLUS,23G,10K VALVE STD/ 8065752435;
TOTAL PLUS,23GA,10K VALVE WD/ 8065752436;
TOTAL PLUS,25+,10K VALVE STD/ 8065752437;
TOTAL PLUS,25+,10K VALVE WD/ 8065752438;
TOTAL PLUS,27+,10K VALVE STD/ 8065752439;
23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448;
23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449;
25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450;
25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451;
27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452;
25+TTLPL VPK 20000CPM BEV VAL/ 8065753106;
27+TTLPL VPK 20000CPM BEV VL/ 8065753109;
HYPERVIT 25+BEV 20000 CPM/ 8065830026;
HYPERVIT 27+BEV 20000 CPM/ 8065830027;
25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077;
25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15;
VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25;
VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27;
23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09;
AUS-25GA VIT RET BRISBANE WATERS/ 12641-13;
AUS-25GA VIT RET BRISBANE WATERS/ 12641-14;
AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16;
23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08;
25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10;
23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13;
25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15;
VITRECTOMY 25G V A HOSPITAL/ 14129-10;
J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12;
CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09;
CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09;
CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10;
CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06;
CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07;
CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08;
CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16;
CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07;
CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15;
CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10;
CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11;
CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09;
CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11;
CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06;
CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07;
CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08;
CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09;
CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07;
CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08;
CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06;
CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07;
CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09;
CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08;
25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13;
CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14;
CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12;
CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05;
CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06;
CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07;
CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07;
CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13;
CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14;
CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08;
CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09;
CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10;
CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04;
CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05;
CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06;
CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05;
CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05;
23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05;
23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06;
27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02;
27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03;
25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05;
25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06;
CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04;
CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05;
CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1 |
| Z-0835-2025 | Alcon Research LLC | 1 | Brand Name: Alcon
Product Name: Monarch III D Delivery Cartridge
Model/Catalog Number: 8065977763
Product Description: Monarch III D delivery cartridge
Lens Guide, Intraocular
Component: N/A |
| Z-0939-2026 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Custom Pak
Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10
Software Version: N/A
Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure.
Component: N/A |
| Z-1293-2025 | Alcon Research LLC | 2 | Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09 |
| Z-1794-2020 | Alcon Research LLC | 2 | Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX. |
| Z-1922-2024 | Alcon Research LLC Aspex Facility | 1 | 20 Gauge V-Lance Knife
Model/Catalog Number: 8065912001
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-1923-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut Sideport Knife Dual Bevel 1.2mm Angled
Model/Catalog Number: 8065921541
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Z-1924-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut S Safety Sideport Knife 1.0mm Dual Bevel
Model/Catalog Number: 8065771540
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Z-1925-2024 | Alcon Research LLC Aspex Facility | 1 | ClearCut S Safety Sideport Knife 1.2mm Dual Bevel
Model/Catalog Number: 8065771541
Software Version: N/A
Product Description: Ophthalmic Knife
Component: N/A |
| Z-2108-2025 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Vitrectomy Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console.
Component: N/A |
| Z-2109-2025 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Constellation Vision System Combined Procedure Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Product Description: Surgical procedure pack to interface with Alcon Constellation Surgical console.
Component: N/A |
| Z-2110-2025 | Alcon Research LLC | 2 | Brand Name: Alcon Laboratories, Inc.
Product Name: Custom Pak
Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List'
Software Version: N/A
Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure.
Component: N/A |
| Z-2287-2020 | Alcon Research LLC Aspex Facility | 3 | Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT FILTER. 13.0mm. LENGTH, 6.0mm ANTERIOR ASYMMETRIC BICONVEX OPTIC, PLANAR HAPTICS. |
| Z-2412-2024 | Alcon Research LLC Aspex Facility | 1 | Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399 |
| Z-2645-2024 | Alcon Research LLC Aspex Facility | 1 | Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel
Model/Catalog Number: 8065771540
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2646-2024 | Alcon Research LLC Aspex Facility | 2 | Product Name: 25GA VALVED ENTRY SYSTEM,3CT
Model/Catalog Number: 8065751658
Software Version: N/A
Product Description: Valved Trocar Entry System
Component: N/A |
| Z-2647-2024 | Alcon Research LLC Aspex Facility | 2 | Product Name: 25+ TTL PLUS VPAK 20000CPM BWV
Model/Catalog Number: 8065830077
Software Version: N/A
Product Description: Standardized assemblage of components, which includes the valved trocar entry system, that interface with the CONSTELLATION Vision System.
Component: N/A |
| Z-2648-2024 | Alcon Research LLC Aspex Facility | 2 | Product Name: Alcon Custom Pak
Model/Catalog Number: Many
Software Version: N/A
Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure.
Component: N/A |
| Z-2649-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: ClearCut S Safety Sideport Knife 1.2mm Dual Bevel
Model/Catalog Number: 8065771541
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2650-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2
Model/Catalog Number: 8065772245
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2651-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.2
Model/Catalog Number: 8065772265
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2652-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.4
Model/Catalog Number: 8065772445
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2653-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT SAFETY INTREPID DB,2.4
Model/Catalog Number: 8065772465
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2654-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT SAFETY SLIT SB,2.75MMANG
Model/Catalog Number: 8065772745
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2655-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN
Model/Catalog Number: 8065911901
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2656-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: 20 Gauge V-Lance Knife
Model/Catalog Number: 8065912001
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2657-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled
Model/Catalog Number: 8065921541
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2658-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: ClearCut Sideport Knife Dual Bevel 1.2mm Angled
Model/Catalog Number: 8065982465
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2659-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.0MM ANGCE
Model/Catalog Number: 8065983065
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2660-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE
Model/Catalog Number: 8065983265
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2661-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: A-OK SATINCRESCENT FULL HANDLE2.3MM ANG
Model/Catalog Number: 8065990002
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2662-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG
Model/Catalog Number: 8065992245
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2663-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG
Model/Catalog Number: 8065992445
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Z-2664-2024 | Alcon Research LLC Aspex Facility | 1 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG
Model/Catalog Number: 8065992561
Software Version: N/A
Product Description: Ophthalmic knife
Component: N/A |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3013785060 | CAMDEN PASSAGE | Collingwood Ontario, CA |
| 3008585940 | GEO MEDICAL CO., LTD | Buk-gu Gwangju, KR |
| 3005994941 | SOLOTICA INDUSTRIA E COMERCIO LTDA | Sao Paulo, BR |
| 3012590738 | EYEYON MEDICAL | Nes Ziona Central, IL |
| 3025414414 | SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD. | Shenzhen Guangdong, CN |
1610287 when referencing this establishment in official correspondence.