Allergan Medical Optics
Country not established
- Devices
- 7
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Allergan Medical Optics makes
Allergan Medical Optics makes intraocular lens implant instruments, ultrasonic handpiece systems, vitrectomy driving systems, and related disposable cartridges and inserters for ophthalmic surgical procedures.
The company's devices are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Amo Profinesse Iii Ultrasonic Handpiece System Ref K951462
Regimes: 510(k) Registry: 510(k)Amo Elite Ref K924235
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Amo(R) Flrx-Tip(Tm) Dispos I/A Handpiece, Opo-38 Ref K925254
Regimes: 510(k) Registry: 510(k)Multitome Model 1000, Vitrectomy Driving System Ref K911998
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Allergan Medical Optics, the earliest on 2003-07-02 and the most recent on 2004-03-29. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 29 Mar 2004 Z-0907-04 Unclassified (pre-2012) Terminated The lots are being recalled because the tray lid may not be adequately sealed under the red arrow in the upper right corner of the package tray. The blue wrapping within the tray may not be sterile and may pose a potential risk of infection to the patient if used in a sterile field.
2003
- 2 Jul 2003 Z-1036-03 Unclassified (pre-2012) Terminated Post operative complaints of cloudiness in the intraocular lenses.
Frequently asked questions
How many devices does Allergan Medical Optics have in the registry?
The registry currently lists 7 devices for Allergan Medical Optics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Allergan Medical Optics's devices?
Among its 7 most recently registered devices, Allergan Medical Optics has devices listed in FDA 510(k) (7 devices).
What risk classes do Allergan Medical Optics's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Allergan Medical Optics's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Allergan Medical Optics?
FDA recall records list 2 recalls initiated by Allergan Medical Optics, the most recent initiated on 29 Mar 2004. 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 Allergan Medical Optics in the registry?
The most recently registered devices listed for Allergan Medical Optics include PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR, AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM, AMO ELITE and AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR.