Z-0409-2022 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
- 680 units
Product Description
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
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: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639