Device product
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Z-1007-2022
Product summary
- Event
- Event 89928
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1225 devices
- Official record key
device-enforcement:Z-1007-2022
Official wording
Reason: High friction of the slider can cause the device to stick, or not move as intended.
Code information: Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410
Distribution pattern: U.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, Puerto Rico, SC, TN, TX. UT, VA, WA, and WV O.U.S.: Not provided
Derived failure modes
-
Unknown
High friction of the slider can cause the device to stick, or not move as intended.