Device product
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK967
Z-0410-2022
Product summary
- Event
- Event 89111
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1170 units
- Official record key
device-enforcement:Z-0410-2022
Official wording
Reason: Kit packaging may have small holes compromising product sterility
Code information: Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371
Distribution pattern: CA, CO, LA, MA, MD, ND, PA, TN, UT
Derived failure modes
-
Unknown
Kit packaging may have small holes compromising product sterility