Akreos, SKU: AO60P0300. Akreos intraocular lenses
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.
US: AZ, CA
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2451-2025