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Recall Observatory FDA recall evidence

Device product

ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.

Z-1007-2022

March 16, 2022

Class II

Product summary

Firm
Carl Zeiss Meditec AG
Event
Event 89928
Status
Ongoing
Classification
Class II
Quantity
1225 devices
Official record key
device-enforcement:Z-1007-2022

Official wording

Reason: High friction of the slider can cause the device to stick, or not move as intended.

Code information: Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    High friction of the slider can cause the device to stick, or not move as intended.