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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1007-2022
Event ID89928
Event DescriptionZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Product TypeDevices
DistributionU.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
Quantity1225 devices
Recall ReasonHigh friction of the slider can cause the device to stick, or not move as intended.
Device Classification20220504
Device Code InfoModel: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410
Center Classification Date20220426
Recall Initiation Date20220316
Recalling FirmCarl Zeiss Meditec AG
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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