FDA-Device2025-09-03Class III
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Bausch & Lomb Surgical, Inc.
Hazard
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.
Sold states
US: AZ, CA
Affected count
2
Manufactured in
21 N Park Place Blvd, Clearwater, FL, United States
Products
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2451-2025Don't want to check this manually?
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