Bausch & Lomb Surgical, Inc. is recalling two Akreos intraocular lenses (SKU: AO60P0300) because they were manufactured with the wrong optical power. The lenses were labeled with a diopter of 3 but were actually manufactured as diopter 16. This error affects lenses from lot 1Q29212 that were distributed to healthcare providers in Arizona and California.
Implanting a lens with the incorrect power can cause functional visual impairment or significantly reduced vision, which would likely require an additional surgery or optical aids to correct.
Firm initiated recall via letter notification.
Quantity affected: 2 units.
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Sources: FDA iRES · Raw API Response
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