Beaver Visitec International, Inc. Recall 89111
Description: Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Beaver Visitec International, Inc. Recall 89111 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0409-2022 |
| Event ID | 89111 |
| Event Description | Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884 |
| Product Type | Devices |
| Distribution | CA, CO, LA, MA, MD, ND, PA, TN, UT |
| Quantity | 680 units |
| Recall Reason | Kit packaging may have small holes compromising product sterility |
| Device Classification | 20211229 |
| Device Code Info | Lot Numbers: 3261518, 3272335, 3278550, 3292632, 3305153, 3326272, 3331632, 3334880, 3344465, 3348295, 3350319, 3357568, 3362608, 3363639 |
| Center Classification Date | 20211221 |
| Recall Initiation Date | 20211117 |
| Recalling Firm | Beaver Visitec International, Inc. |
| Initial Notification | Letter |
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