CLASS II ONGOING Device recall · Reported 4 May 2022 · FDA Enforcement Report

Zeiss miLOOP Lens Fragmentation Device recalled by Carl Zeiss Meditec AG

Carl Zeiss Meditec is recalling Zeiss miLOOP Lens Fragmentation Device, distributed in 32 states. The recall was initiated on 16 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410

Quantity recalled1225 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1007-2022
FDA event ID: 89928
Recalling firm: Carl Zeiss Meditec, Oberkochen
Classification: Class II
Status: Ongoing
Recall initiated: 16 Mar 2022
FDA classified: 26 Apr 2022
Reported: 4 May 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Mar 2022	Recall initiated by company
26 Apr 2022	Classified by FDA	+41 days
4 May 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Alabama Arkansas Arizona California Connecticut Florida Georgia Iowa Illinois Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi Montana North Carolina New Jersey

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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