Device product
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0011-2019
Product summary
- Event
- Event 80569
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-0011-2019
Official wording
Reason: Sterility failure found in one of the units in the lot.
Code information: Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108
Distribution pattern: Distribution US nationwide and Switzerland.
Derived failure modes
-
Unknown
Sterility failure found in one of the units in the lot.