FDAClass IIMay 4, 2022

ZEISS miLOOP Lens Fragmentation Device recall

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

Why was ZEISS miLOOP Lens Fragmentation Device recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Recalling firm
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
Recall date
May 4, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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