Device product
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Z-2451-2025
Product summary
- Event
- Event 97232
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2
- Official record key
device-enforcement:Z-2451-2025
Official wording
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.
Code information: UDI-DI: 10757770501783, Lot: 1Q29212, Serial Numbers: 1Q29212006 and 1Q29212010
Distribution pattern: US: AZ, CA
Derived failure modes
-
Unknown
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.