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.
- Company
- Bausch & Lomb Surgical, Inc.
- Recall Initiated
- October 16, 2013
- Posted
- February 20, 2014
- Terminated
- September 17, 2014
- Recall Number
- Z-1062-2014
- Quantity
- 336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
- Firm Location
- Clearwater, FL
Reason for Recall
Lens was manufactured with incorrect raw material.
Distribution
Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
Lot / Code Info
Model Numbers(s): AO60 and MI60L
Root Cause
Nonconforming Material/Component
Action Taken
The firm, Bausch + Lomb, telephoned and sent an "URGENT - MEDICAL DEVICE RECALL" letter dated October 17, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1) Determine the disposition of the lenses; 2) Complete and provide the enclosed acknowledgement form to the sales respresentatives collecting the lenses, and 3) Return all unused products. If you have any questions, please contact Bausch + Lomb at (800) 338-2020.
More recalls by Bausch & Lomb Surgical, Inc.
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Aug 26, 2025
Intraocular Lens. enVista Envy IOL, All models starting with EN;
enVista Envy Toric IOL, All models...
May 2, 2025
Intraocular lens. enVista Monofocal IOL, All models starting with EE;
enVista Aspire IOL, All models...
May 2, 2025