Class II — Beaver Visitec International, Inc.
| Recalling firm | Beaver-Visitec International, Inc. |
|---|---|
| Registered facility | Beaver-Visitec International, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Kit packaging may have small holes compromising product sterility |
| Product | Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884 |
| Quantity | 680 units |
| Distribution | CA, CO, LA, MA, MD, ND, PA, TN, UT |
| Initiated | 2021-11-17 |
| Classified | 2021-12-21 |
| Recall number | Z-0409-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beaver Visitec International, Inc. (Z-0409-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89111/
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