FDA Medical Device Recalls (openFDA)
Carl Zeiss Meditec AG: ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
- Recall number
- Z-1007-2022
- Recalling firm
- Carl Zeiss Meditec AG
- Product
- ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
- Status
- Open, Classified
- Initiated
- 2022-03-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- High friction of the slider can cause the device to stick, or not move as intended.
- 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 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
- 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
- Lot, serial or model codes
- Model: 303071-9090-000 Catalog Number: FG-50608 UDI: (01)04049539104496(11)201102(17)231031(10)FG21082410 Lot Number: FG21082410
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HNQ
- Firm FEI
- 3003481798
- Firm city
- Oberkochen
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28