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Abbott Medical Optics Recalls
9 recalls on record · June 19, 2013 to April 29, 2015 · Medical Devices
Recalls by year
13
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 29, 2015Medical DevicesFDA
Abbott Medical Optics, Inc. recalls OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: I
Hazard: Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
October 30, 2013Medical DevicesFDA
Abbott Medical Optics, Inc. recalls STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO M
Hazard: 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).
October 30, 2013Medical DevicesFDA
Abbott Medical Optics, Inc. recalls STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufacture
Hazard: 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).
October 30, 2013Medical DevicesFDA
Abbott Medical Optics, Inc. recalls STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed
Hazard: 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).
October 30, 2013Medical DevicesFDA
Abbott Medical Optics, Inc. recalls STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Man
Hazard: 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).
July 17, 2013Medical DevicesFDA
Abbott Medical Optics, Inc. recalls Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Hazard: 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.
June 19, 2013Medical DevicesFDA
Abbott Medical Optics, Inc. recalls STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035
Hazard: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
June 19, 2013Medical DevicesFDA
Abbott Medical Optics, Inc. recalls STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive
Hazard: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
June 19, 2013Medical DevicesFDA
Abbott Medical Optics, Inc. recalls STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 9
Hazard: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.