Device product
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Z-0409-2022
Product summary
- Event
- Event 89111
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 680 units
- Official record key
device-enforcement:Z-0409-2022
Official wording
Reason: Kit packaging may have small holes compromising product sterility
Code information: Lot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639
Distribution pattern: CA, CO, LA, MA, MD, ND, PA, TN, UT
Derived failure modes
-
Unknown
Kit packaging may have small holes compromising product sterility