Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9681121

FEI Number

3002807944

Entity Name

PT. CIBA VISION BATAM

City/State/Country

BATAM ISLAND Riau, ID

Establishment Address

JL BERINGIN LOT No. 204, BATAMINDO INDUSTRIAL PARK, MUKA KUNING, BATAM ISLAND Riau 29433, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Alcon Laboratories, Inc. (Owner Number: 1610287)

Owner / Operator Contact Address

6201 South Freeway, Fort Worth, TX 76134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101285

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPL	Lenses, Soft Contact, Daily Wear	Ophthalmic	Class 2	886.5925	2019-08-22
POE	Extended Depth Of Focus Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-11-21
MFK	Lens, Multifocal Intraocular	Ophthalmic	Class 3	886.3600	2007-11-21
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-11-21
MJP	Lens, Intraocular, Toric Optics	Ophthalmic	Class 3	886.3600	2007-11-21
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-04-19
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	Class 2	886.4150	2012-04-19
HQB	Photocoagulator And Accessories	Ophthalmic	Class 2	886.4690	2012-04-19
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-04-19
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2024-04-03
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-11-21
HQL	Intraocular Lens	Ophthalmic	Class 3	886.3600	2007-11-21
LPM	Lenses, Soft Contact, Extended Wear	Ophthalmic	Class 3	886.5925	2013-10-30
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2011-12-14

Official Correspondent

No official correspondent registered.

US Agent Details

Dale Schaper Business: ALCON LABORATORIES, INC. Email: dale.schaper@alcon.com Phone: (817) 5686421

Related Public Records

Same Entity

Alcon Laboratories, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K003161	Les Laboratoires Blanchard	ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT	2000-12-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
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-0018-07	Ciba Vision Corporation	2	CSI Daily Wear, soft (hydrophilic) contact lenses
Z-0019-07	Ciba Vision Corporation	2	CSI Flexible Wear, soft (hydrophilic) contact lenses
Z-0020-07	Ciba Vision Corporation	2	CSI Toric, soft (hydrophilic) contact lenses

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9681121. Last updated year: 2026. Please use registration number 9681121 when referencing this establishment in official correspondence.