ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000.… recallZ-1007-2022 · Carl Zeiss Meditec AG · initiated Mar 16, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carl Zeiss Meditec AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
High friction of the slider can cause the device to stick, or not move as intended.
FDA root cause category: Under Investigation by firm
What the company is doing
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]
Recall details
- Recall number
- Z-1007-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 16, 2022
- Recalling firm
- Carl Zeiss Meditec AG
- Quantity
- 1225 devices
- Product code
- HNQ
- 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 description
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Code information (models, lots, serial numbers)
Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- miLOOP 303071-9090-000Carl Zeiss Meditec AG · Hook, Ophthalmic1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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