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Recall Observatory FDA recall evidence

Device product

Akreos, SKU: AO60P0300. Akreos intraocular lenses

Z-2451-2025

June 06, 2025

Class III

Product summary

Firm
Bausch & Lomb Surgical, Inc.
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

    reason.no_named_rule · v1.0.0

    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.