Recall Z-3277-2018 ยท HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Bausch & Lomb Inc
Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Wide-Field Elite Pack, REF SE5525WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
| Date | Aug 8, 2018 |
| Status | Terminated |
| Reason | The back cap separates from the body of the vitrectomy cutter. |
| Root cause | Nonconforming Material/Component |
| Action | Recall letters flagged URGENT MEDICAL DEVICE VOLUNTARY RECALL dated 8/8/2018 were issued 8/8/2018 via certified mail return receipt to the U.S. consignees. Letters for foreign consignees were dated 8/7/2018 and were flagged URGENT FIELD SAFETY NOTICE. |
| Quantity | 10 cases |
| Distribution | Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Swi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162342 | Stellaris Elite Vision Enhancement System Bausch+Lomb, Mar 24, 2017 |