Reported Feb 26, 2014 · Terminated
Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the…
Bausch & Lomb Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bausch & Lomb Surgical, Inc. · 21 N Park Place Blvd · Clearwater, FL · 33759-3917
Is this the product you have?
- 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.
- Lot codes and dates
- Model Numbers(s)AO60 and MI60L
- Amount recalled
- 336 IOLs (283 IOLs in the US, 53 IOLs outside the US)
Where it was sold
- Nationwide
Why it was recalled
Lens was manufactured with incorrect raw material.
This product could cause temporary or reversible health problems — stop using it.
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