Recall Z-0593-2013 ยท HQC Unit, Phacofragmentation
Bausch & Lomb Inc
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.
| Date | Dec 20, 2012 (initiated Aug 31, 2012) |
| Status | Terminated |
| Reason | Posterior fluidics modules installed in the system may need to be recalibrated. |
| Root cause | Process control |
| Action | "Urgent Product Recall" notification letters dated August 31, 2012 were issued via first class mail, e-mail, and/or phone calls to affected customers. The product issue and the field correction was provided. Customers in the US may contact 1-800 338-2020 for questions. |
| Quantity | 124 units |
| Distribution | Worldwide Distribution was made in the U.S., Canada, Australia, Singapore, Korea, Switzerland, France, Germany, United Kingdom, Portugal, Italy, Spain, Ireland, Africa, UAE, Jordan, Turkey, Ukraine, and Lebanon. There was no government or military distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101325 | STELLARIS PC VISION ENHANCEMENT SYSTEM Bausch & Lomb, Inc., Aug 17, 2010 |