Device product
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Z-1062-2014
Product summary
- Event
- Event 67283
- Status
- Terminated
- Classification
- Class II
- Quantity
- 336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
- Official record key
device-enforcement:Z-1062-2014
Official wording
Reason: Lens was manufactured with incorrect raw material.
Code information: Model Numbers(s): AO60 and MI60L
Distribution pattern: Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
Derived failure modes
-
Unknown
Lens was manufactured with incorrect raw material.