Recall Z-1007-2022 ยท HNQ Hook, Ophthalmic
Carl Zeiss Meditec AG
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
| Date | Mar 16, 2022 |
| Status | Open, Classified |
| Reason | High friction of the slider can cause the device to stick, or not move as intended. |
| Root cause | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.