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Terminated

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

FDA Recall Z-0983-2017 · Posted 2017-01-10

Recalling FirmBausch & Lomb, Inc.
Recall StatusTerminated
Product CodeOHW
Date Initiated2016-10-12
Date Terminated2017-07-14
Product Quantity2487 units Domestic (USA), 1,211 units Foreign (outside USA)

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investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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

Firm Action

Bausch + Lomb sent an Urgent Medical Device Voluntary Field Correction letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Bausch + Lomb customer service at 1-800-338-2020

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution - US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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