Device product
Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
Z-3271-2018
Product summary
- Event
- Event 80837
- Status
- Terminated
- Classification
- Class II
- Quantity
- 131 cases
- Official record key
device-enforcement:Z-3271-2018
Official wording
Reason: The back cap separates from the body of the vitrectomy cutter.
Code information: Lot numbers V9301, exp. 10/17/2018; V9401, exp. 11/6/2018; V9708, exp. 12/4/2018; W1019, exp. 6/23/2019; and W1675, exp. 9/24/2019, UDI 00757770058914.
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.