Recall Z-1062-2014 ยท HQL Intraocular Lens
Bausch & Lomb Surgical, Inc.
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.
| Date | Feb 20, 2014 (initiated Oct 16, 2013) |
| Status | Terminated |
| Reason | Lens was manufactured with incorrect raw material. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 336 IOLs (283 IOLs in the US, 53 IOLs outside the US) |
| Distribution | Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.