Z-0410-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 29, 2021
- Initiation Date
- November 17, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1170 units
Product Description
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
Reason for Recall
Kit packaging may have small holes compromising product sterility
Distribution Pattern
CA, CO, LA, MA, MD, ND, PA, TN, UT
Code Information
Lot Numbers: 3347922, 3350452, 3354937, 3358047, 3364371