Z-0983-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- October 12, 2016
- Termination Date
- July 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2487 units Domestic (USA), 1,211 units Foreign (outside USA)
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
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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.
Distribution Pattern
Worldwide Distribution - US Nationwide
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