Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient
Published January 18, 2017 · Recall initiated: October 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Bausch & Lomb, Inc.
- Distributor
- Worldwide Distribution - US Nationwide
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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