ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000 — Class II medical device recall Z-1007-2022
Ongoing recall by Carl Zeiss Meditec AG, reported 2022-05-04, distributed in AL, AR, AZ, CA, CT, FL, GA, IA…. High friction of the slider can cause the device to stick, or not move as intended.
| Recall number | Z-1007-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec AG, Oberkochen, Germany |
| Recall initiated | 2022-03-16 |
| Classified | 2022-04-26 |
| Reported by FDA | 2022-05-04 |
| Distributed | 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 |
| Quantity | 1,225 devices |
| UPC / GTIN / UDI-DI | 04049539104496 |
| Lot numbers | FG21082410 |
| Model numbers | 303071-9090-000, FG-50608 |
Product
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Reason for recall
High friction of the slider can cause the device to stick, or not move as intended.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1007-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.