Recall Z-3089-2011 ยท HQC Unit, Phacofragmentation
Bausch & Lomb Inc
Bausch & Lomb Stellaris Optimized Stability Vacuum Pack, Ref: BL5112, 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
| Date | Aug 30, 2011 (initiated Jul 27, 2011) |
| Status | Terminated |
| Reason | The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 2/6-unit cases |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082473 | BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM Bausch & Lomb, Inc., Jan 5, 2009 |