Reported Jan 18, 2017 · Terminated
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies…
Bausch & Lomb, 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, Inc. · 1501 Graves Mill Rd · Lynchburg, VA · 24502-4328
Is this the product you have?
- Algerbrush-II Product UsageMedical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
- Lot codes and dates
- LOT #(s) AND EXPIRATION DATES, SERIAL #(s), ORDER #, or OTHER IDENTIFICATION #(s): SKU E0815 A, SKU E0815 B, SKU E0815 0.5, SKU E0815 1.0 and SKU E0816 C
- Amount recalled
- 2487 units Domestic (USA), 1,211 units Foreign (outside USA)
Where it was sold
- Nationwide
Why it was recalled
According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.
This product could cause temporary or reversible health problems — stop using it.
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