FDA Device recall Z-1007-2022
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000
- FDA Device
- Class II
- ongoing
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000 by Carl Zeiss Meditec Ag, citing high friction of the slider can cause the device to stick, or not move as intended.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1007-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-16 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Carl Zeiss Meditec Ag |
| Distribution | AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, WA, WV |
Product
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Reason
High friction of the slider can cause the device to stick, or not move as intended.
Identifiers
| code_info | Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410 |
|---|
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-1007-2022%22
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