FDAMarch 16, 2022device
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
High friction of the slider can cause the device to stick, or not move as intended.
What to do
FDA enforcement status: Ongoing
Brands named
carl zeiss meditec agcarlcarl zeiss
UPCs
303071909000004049539104496
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAOPMI LUMERA 300, REF 61372023-08-18
- FDAZEISS Axio Observer 5 microscope, Product material no. 431006-9901-0002022-06-24
- FDACIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex2022-01-14
- FDAChassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"2021-07-08
- FDAIOLMaster 7002020-12-07
- FDACarl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.2020-08-06
- FDACarl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses and contact lenses.2020-08-06
- FDAComponent for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900)2019-10-02
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