Carl Zeiss Meditec AG Recall 89928
Description: ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Carl Zeiss Meditec AG Recall 89928 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1007-2022 |
| Event ID | 89928 |
| Event Description | ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery. |
| Product Type | Devices |
| Distribution | U.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, Puerto Rico, SC, TN, TX. UT, VA, WA, and WV O.U.S.: Not provided |
| Quantity | 1225 devices |
| Recall Reason | High friction of the slider can cause the device to stick, or not move as intended. |
| Device Classification | 20220504 |
| Device Code Info | Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410 |
| Center Classification Date | 20220426 |
| Recall Initiation Date | 20220316 |
| Recalling Firm | Carl Zeiss Meditec AG |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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