Carl Zeiss IOL Master 5.5 Software Recall for Incorrect Data
Carl Zeiss Meditec AG is recalling IOL Master 5.5 software versions 7.5 and 7.7 because printouts and reports may contain incorrect IOL power data.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product where incorrect data could lead to improper medical decisions, though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Carl Zeiss Meditec AG is recalling 49 units of IOL Master 5.5 software, specifically versions 7.5 and 7.7. This ophthalmic device is used to obtain ocular measurements and perform calculations that allow physicians to determine the appropriate intraocular lens (IOL) power and type for implantation.
The recall was initiated because calculation printouts and exported reports generated by these software versions can contain the wrong IOL power data. The affected units were distributed nationwide.
Healthcare providers and consumers should stop using the affected software versions and contact the manufacturer for further instructions on remediation.
The recalled product
- Product
- 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.
- Manufacturer
- Carl Zeiss Meditec AG
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 49
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Carl Zeiss Meditec AG under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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