Z-1062-2014 Class II Terminated
FDA device recall Z-1062-2014 was initiated by Bausch & Lomb Surgical, Inc. on Oct 16, 2013 and is designated Class II. Reason for recall: Lens was manufactured with incorrect raw material. The recall status is terminated (terminated Sep 17, 2014). Affected quantity: 336 IOLs (283 IOLs in the US, 53 IOLs outside the US).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 26, 2014
- Initiation Date
- Oct 16, 2013
- Termination Date
- Sep 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