Entity profile compiled from public source records
| Submission # | Device Name | Decision Date | Decision Description | Action |
|---|---|---|---|---|
| K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | 2010-09-15 | Substantially Equivalent | View Details |
| K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | 2011-12-21 | Substantially Equivalent | View Details |
| K111697 | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM | 2011-09-27 | Substantially Equivalent | View Details |
| K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | 2012-10-15 | Substantially Equivalent | View Details |
| K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | 2014-02-27 | Substantially Equivalent | View Details |
| K151783 | COMPACT INTUITIV Multiple-Use Pack | 2015-09-02 | Substantially Equivalent | View Details |
| K170322 | Catalys Precision Laser System | 2017-05-19 | Substantially Equivalent | View Details |
| Recall # | Product Description | Initiation Date | Status | Action |
|---|---|---|---|---|
| Z-0046-2014 | STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. Reason: This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). | 2013-09-16 | Terminated | View Details |
| Z-0047-2014 | STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. Reason: This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). | 2013-09-16 | Terminated | View Details |
| Z-0048-2014 | STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. Reason: This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). | 2013-09-16 | Terminated | View Details |
| Z-0049-2014 | STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations. Reason: This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). | 2013-09-16 | Terminated | View Details |
| Z-1515-2015 | OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens. Reason: Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation. | 2015-02-20 | Terminated | View Details |
| Z-1539-2013 | STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. Reason: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. | 2013-05-28 | Terminated | View Details |
| Z-1540-2013 | STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. Reason: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. | 2013-05-28 | Terminated | View Details |
| Z-1541-2013 | STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. Reason: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. | 2013-05-28 | Terminated | View Details |
| Z-1670-2013 | Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery. Reason: Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery. | 2013-05-23 | Terminated | View Details |
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