FDAOctober 27, 2015device
IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
What to do
FDA enforcement status: Terminated
Brands named
carl zeiss meditec agcarlcarl zeiss
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
- FDAZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.2022-03-16
- 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
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →