Recall Z-0983-2017— Bausch & Lomb, Inc.
Class II · Terminated
Class II FDA medical device recall by Bausch & Lomb, Inc., initiated 2016-10-12, terminated 2017-07-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient. Reason: 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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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..
- Recalling firm
- Bausch & Lomb, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-12
- Terminated
- 2017-07-14
- Firm location
- Lynchburg, VA, United States
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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.