FDA-Device2014-02-26Class II
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Bausch & Lomb Surgical, Inc.
Hazard
Lens was manufactured with incorrect raw material.
Sold states
Worldwide Distribution: US (nationwide) and Internationally to: Great Britain, France, Spain, Portugal, Sweden, Russia and Guadeloupe.
Affected count
336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
Manufactured in
21 N Park Place Blvd, Clearwater, FL, United States
Products
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1062-2014Don't want to check this manually?
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