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U.S. Department of Health and Human Services

Class 2 Device Recall miLOOP Lens Fragmentation Device

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  Class 2 Device Recall miLOOP Lens Fragmentation Device see related information
Date Initiated by Firm March 16, 2022
Create Date April 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-1007-2022
Recall Event ID 89928
Product Classification Hook, ophthalmic - Product Code HNQ
Product ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Code Information Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410
Recalling Firm/
Manufacturer		 Carl Zeiss Meditec AG
Rudolf-Eber-Str. 11
Oberkochen Germany
For Additional Information Contact Scott Smith
704-906-3287
Manufacturer Reason
for Recall		 High friction of the slider can cause the device to stick, or not move as intended.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 03/16/2022, the Recalling firm called U.S. Customers to inform them of that is has been determined that single lot (Lot FG21082410) of the ZEISS miLoop may have been provided with potentially too high friction of the slider. A follow-up email was sent on 03/22/2022 that contained an "Urgent Medical Device Recall" letter. Customer are asked to discontinue the use and not to further distribute the specific product lot, and to fill out the attached acknowledgement form to dl.med-qualitycti.us@zeiss.com. Customer are asked to return all devices from lot FG21082410 to Carl Zeiss Meditec AG. For question or assistance, contact: Scott Smith, Director of Sales at (704) 906-3287 or email scott.smith@zeiss.com
Quantity in Commerce 1225 devices
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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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