CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Algerbrush-II Product Usage: Medical - For surgeons to use recalled

Bausch & Lomb is recalling Algerbrush-II Product Usage: Medical - For surgeons to use in, distributed nationwide in the US. The recall was initiated on 12 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLOT #(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

Quantity recalled2487 units Domestic (USA), 1,211 units Foreign (outside USA)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0983-2017
FDA event ID: 75915
Recalling firm: Bausch & Lomb, Lynchburg, VA
Classification: Class II
Status: Terminated
Recall initiated: 12 Oct 2016
FDA classified: 9 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

12 Oct 2016	Recall initiated by company
9 Jan 2017	Classified by FDA	+89 days
18 Jan 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribution - US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Worldwide Distribution - US Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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