FDA-Device2017-01-18Class II
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
Bausch & Lomb, Inc.
Hazard
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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.
Sold states
Worldwide Distribution - US Nationwide
Affected count
2487 units Domestic (USA), 1,211 units Foreign (outside USA)
Manufactured in
1501 Graves Mill Rd, Lynchburg, VA, United States
Products
Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2017Don't want to check this manually?
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