Bausch & Lomb, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0983-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.
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

Product Classification:

Class II

Date Initiated: October 12, 2016
Date Posted: January 18, 2017
Recall Number: Z-0983-2017
Event ID: 75915
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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.

Status: Terminated
Product Quantity: 2487 units Domestic (USA), 1,211 units Foreign (outside USA)
Code Information:

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

Distribution Pattern:

Worldwide Distribution - US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated