Z-1062-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2014
- Initiation Date
- October 16, 2013
- Termination Date
- September 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
Product Description
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.
Reason for Recall
Lens was manufactured with incorrect raw material.
Distribution Pattern
Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
Code Information
Model Numbers(s): AO60 and MI60L