Recall archive / FDA device enforcement
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery. — FDA record Z-1007-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Carl Zeiss Meditec AG
- Quantity
- 1225 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1007-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 4, 2022
- Recall initiation date
- Mar 16, 2022
- Center classification date
- Apr 26, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.