FDA Device recall Z-2451-2025
Akreos, SKU: AO60P0300
- FDA Device
- Class III
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class III recall of Akreos, SKU: AO60P0300 by Bausch And Lomb Surgical, citing 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 visu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2451-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-06-06 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Bausch And Lomb Surgical |
| Distribution | AZ, CA |
Product
Akreos, SKU: AO60P0300. Akreos intraocular lenses
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.
Identifiers
| code_info | UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2451-2025%22
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