FDA Device recall Z-0405-2022
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery
- FDA Device
- Class II
- ongoing
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery by Beaver Visitec International, citing kit packaging may have small holes compromising product sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0405-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-17 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beaver Visitec International |
| Distribution | CA, CO, LA, MA, MD, ND, PA, TN, UT |
Product
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2
Reason
Kit packaging may have small holes compromising product sterility
Identifiers
| code_info | Lot Numbers: 3309015, 3347920, 3351630, 3356836, 3360219, 3364419 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0405-2022%22
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