Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery
This recall has been terminated (originally issued August 30, 2011).
- Company
- Bausch & Lomb Inc
- Recall Initiated
- July 27, 2011
- Posted
- August 30, 2011
- Terminated
- June 21, 2013
- Recall Number
- Z-3088-2011
- Quantity
- 229/6-unit cases
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction
Distribution
Nationwide Distribution.
Lot / Code Info
Model # BL5111, Lot #U6481, Exp. 11/2012.
Root Cause
Nonconforming Material/Component
Action Taken
Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011 The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product. For question on this recall contact Bausch & Lomb at (949) 521-7895.
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