Device product
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.
Z-3277-2018
Product summary
- Event
- Event 80837
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 cases
- Official record key
device-enforcement:Z-3277-2018
Official wording
Reason: The back cap separates from the body of the vitrectomy cutter.
Code information: Lot number W0788, exp. 5/11/2019, UDI 00757770059683.
Distribution pattern: 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, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.
Derived failure modes
-
Unknown
The back cap separates from the body of the vitrectomy cutter.