PlainRecalls
FDA Devices Moderate Class II Terminated

Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

Reported: January 18, 2017 Initiated: October 12, 2016 #Z-0983-2017

Product Description

Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

Reason for Recall

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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.

Details

Recalling Firm
Bausch & Lomb, Inc.
Units Affected
2487 units Domestic (USA), 1,211 units Foreign (outside USA)
Distribution
Worldwide Distribution - US Nationwide
Location
Lynchburg, VA

Frequently Asked Questions

What product was recalled?
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient. Recalled by Bausch & Lomb, Inc.. Units affected: 2487 units Domestic (USA), 1,211 units Foreign (outside USA).
Why was this product 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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-0983-2017.