FDA Device recall Z-0407-2022
Malosa Core Phaco Pack 1-Medical Cataract 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 Phaco Pack 1-Medical Cataract 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-0407-2022 |
| 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 Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
Reason
Kit packaging may have small holes compromising product sterility
Identifiers
| code_info | Lot Numbers: 3272267, 3274728, 3323887 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Beaver Visitec International
- BVI Leos Laser and Endoscopy System
FDA Device · Class II · 2026-01-07 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001417
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58000775
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001568
FDA Device · Class II · 2024-09-04 · Beaver Visitec International - BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001020
FDA Device · Class II · 2024-09-04 · Beaver Visitec International
All Beaver Visitec International recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0407-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.