FDA Enforcement
Class II
Ongoing
Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
Recall: Z-0406-2022
·
Reported December 29, 2021
Enforcement
- Recall Number
- Z-0406-2022
- Event ID
- 89111
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Beaver Visitec International, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 29, 2021
- Initiation Date
- November 17, 2021
- Classification Date
- December 21, 2021
- Address
- 500 Totten Pond Rd, 10 City Point, Waltham, MA, 02451-1916, United States
Description
Malosa Core Suface Treatment Pack -Medical Corneal Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK110/3
Reason
Kit packaging may have small holes compromising product sterility
Code Info
Lot Numbers: 3347921, 3358240
Distribution
CA, CO, LA, MA, MD, ND, PA, TN, UT
Quantity
380 units