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U.S. Department of Health and Human Services

Class 2 Device Recall AlgerbrushII

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 Class 2 Device Recall AlgerbrushIIsee related information
Date Initiated by FirmOctober 12, 2016
Date PostedJanuary 10, 2017
Recall Status1 Terminated 3 on July 14, 2017
Recall NumberZ-0983-2017
Recall Event ID 75915
Product Classification Burr, corneal, battery powered, rust ring removal - Product Code OHW
ProductAlgerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
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 
Recalling Firm/
Manufacturer		 Bausch & Lomb, Inc.
1501 Graves Mill Rd
Lynchburg VA 24502-4328
For Additional Information Contact
434-385-0407
Manufacturer 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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.
FDA Determined
Cause 2		Error in labeling
ActionBausch + 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 Commerce2487 units Domestic (USA), 1,211 units Foreign (outside USA)
DistributionWorldwide Distribution - US Nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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