Recall Z-2451-2025 ยท HQL Intraocular Lens
Bausch & Lomb Surgical, Inc.
Akreos, SKU: AO60P0300. Akreos intraocular lenses
| Date | Aug 26, 2025 (initiated Jun 6, 2025) |
| Status | Open, Classified |
| Reason | An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction. |
| Root cause | Process control |
| Action | 6/6/2025, recall notices were emailed to customers who were asked to do the following: 1) Check your inventory, quarantine, and do not use the IOL from this impacted lot. 2) Provide this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred (as appropriate). Also, please transfer this notice to other organizations on which this action has an impact (as appropriate). Please maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective actio |
| Quantity | 2 |
| Distribution | US: AZ, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.