ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
FDA Recall Z-1007-2022 · Posted None
Recalling FirmCarl Zeiss Meditec AG
Recall StatusOpen, Classified
Product CodeHNQ
Date Initiated2022-03-16
Product Quantity1225 devices
Reason for Recall
High friction of the slider can cause the device to stick, or not move as intended.
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 [email protected]. 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 [email protected]
Root Cause
Under Investigation by firm
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.