Abbott Medical Optics, Inc.
United StatesFDA applicant, unverified
- Devices
- 22
- FDA recalls
- 9
At a glance
Market reach
- United States
- FDA recalls
What Abbott Medical Optics, Inc. makes
The company manufactures phacoemulsification systems and related accessories for cataract surgery, including standalone units like the Sovereign Compact and AMO Whitestar Signature systems, as well as laser-assisted platforms such as the Catalys Precision and IFS Laser systems. Additional components include laminar flow phaco tips, irrigation sleeves, single-use and reusable fluidics packs, wireless foot pedals, and cartridge-based fragmentation units like the One Series Ultra.
These devices are regulated under FDA pathways, with most classified as Class II or Class III, requiring either 510(k) clearance or PMA approval. Some accessories fall under Class I, subject to general controls. The company’s products are listed in the FDA’s 510(k) and PMA registries, reflecting their authorised status for commercial distribution in the US.
Catalogue
Search and filter all 22 devicesFDA recalls
FDA recall records list 9 recalls initiated by Abbott Medical Optics, Inc., the earliest on 2013-05-23 and the most recent on 2015-02-20. By recorded status: 9 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 20 Feb 2015 Z-1515-2015 Class II Terminated Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
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- 20 Feb 2015 Z-1515-2015 Class II Terminated Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation.
2013
- 16 Sep 2013 Z-0046-2014 Class II Terminated 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).
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- 16 Sep 2013 Z-0047-2014 Class II Terminated 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).
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- 16 Sep 2013 Z-0048-2014 Class II Terminated 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).
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- 16 Sep 2013 Z-0049-2014 Class II Terminated 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).
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- 28 May 2013 Z-1539-2013 Class II Terminated Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
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- 28 May 2013 Z-1540-2013 Class II Terminated Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
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- 28 May 2013 Z-1541-2013 Class II Terminated Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.
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- 23 May 2013 Z-1670-2013 Class II Terminated 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.
- 16 Sep 2013 Z-0046-2014 Class II Terminated 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).
Frequently asked questions
How many devices does Abbott Medical Optics, Inc. have in the registry?
The registry currently lists 22 devices for Abbott Medical Optics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott Medical Optics, Inc.'s devices?
Among its 22 most recently registered devices, Abbott Medical Optics, Inc. has devices listed in FDA 510(k) (13 devices) and FDA PMA (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Abbott Medical Optics, Inc.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for Abbott Medical Optics, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Abbott Medical Optics, Inc.?
FDA recall records list 9 recalls initiated by Abbott Medical Optics, Inc., the most recent initiated on 20 Feb 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Abbott Medical Optics, Inc. in the registry?
The most recently registered devices listed for Abbott Medical Optics, Inc. include SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM, Dual Pump Pack, LAMINAR FLOW PHACO TIPS and UNIT, PHACOFRAGMENTATION.