ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000…

Date

May 4, 2022

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Ongoing

Filed by

Carl Zeiss Meditec AG

Product

ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.

Reason

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

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

Quantity

1225 devices

Codes and lots

Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410

Recall started

March 16, 2022

Device type

Hook, Ophthalmic

Root cause (FDA)

Under Investigation by firm

What the company told customers

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

Recall number

Z-1007-2022

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1007-2022. The agency record governs; check it and the company before acting.