Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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

Distribution

As reported by FDA

AL, AZ, AR, CA, CT, FL, GA, IL, IA, KS, LA, MD, MA, MI, MN, MS, MO, MT, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, PR