Device product
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
Z-0407-2022
Product summary
- Event
- Event 89111
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120 units
- Official record key
device-enforcement:Z-0407-2022
Official wording
Reason: Kit packaging may have small holes compromising product sterility
Code information: Lot Numbers: 3272267, 3274728, 3323887
Distribution pattern: CA, CO, LA, MA, MD, ND, PA, TN, UT
Derived failure modes
-
Unknown
Kit packaging may have small holes compromising product sterility