Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies fr

FDA device recall Z-0983-2017 · posted 2017-01-10 · Terminated

Recall details

Recalling firm

Bausch & Lomb, Inc.

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investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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

Action taken

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

Status

Terminated

Product code

OHW

Quantity affected

2487 units Domestic (USA), 1,211 units Foreign (outside USA)

Distribution

Worldwide Distribution - US Nationwide

Date initiated

2016-10-12

Date posted

2017-01-10

Date terminated

2017-07-14

Location

Lynchburg, VA