Z-1007-2022Class II

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

Name: Z-1007-2022 ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery
Creator: Carl Zeiss Meditec AG
Published: 2022-03-16
License: https://open.fda.gov/license/

Carl Zeiss Meditec Inc / initiated 2022-03-16 / Open, Classified

FDA source

Carl Zeiss Meditec AG began a recall of ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery on 2022-03-16. FDA classified it as Class II and gives the reason as "High friction of the slider can cause the device to stick, or not move as intended". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1007-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-16
Posted: 2022-04-26
Recalling firm: Carl Zeiss Meditec Inc
Product: ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Product code: HNQ Hook, Ophthalmic
Reason for recall: High friction of the slider can cause the device to stick, or not move as intended.
FDA 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 [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]
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
Product codes and lots: Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1007-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1007-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-26

Product code HNQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)