Z-0983-2017Class II

Algerbrush-II

Name: Z-0983-2017 Algerbrush-II
Creator: Bausch & Lomb, Inc.
Published: 2016-10-12
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2016-10-12 / Terminated / root cause: labeling and UDI

FDA source

Bausch & Lomb, Inc. began a recall of Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient on 2016-10-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0983-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-12
Posted: 2017-01-10
Terminated: 2017-07-14
Recalling firm: Bausch & Lomb Incorporated
Product: Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
Product code: OHW Burr, Corneal, Battery Powered, Rust Ring Removal
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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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
Quantity in commerce: 2487 units Domestic (USA), 1,211 units Foreign (outside USA)
Distribution: Worldwide Distribution - US Nationwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0983-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0983-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code OHW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)