Carl Zeiss IOL Master 500 Software Recall for Incorrect IOL Power Data
Carl Zeiss Meditec is recalling IOL Master 500 software versions 7.5 and 7.7 because calculation printouts and exported reports may contain incorrect intraocular lens power data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 defect involves incorrect medical data (IOL power) which poses a risk of harm to patients, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Carl Zeiss Meditec AG is recalling 1,882 units of the IOL Master 500 ophthalmic device, specifically software versions 7.5 and 7.7. The recall was initiated because calculation printouts and exported reports generated by these software versions can contain incorrect intraocular lens (IOL) power data.
The IOL Master 500 is intended for the biometric determination of ocular measurements, including axial length, anterior chamber depth, corneal radius, white-to-white (WTW), and pupil size. The affected units were distributed nationwide. The source text does not specify the exact dates of distribution or the specific facilities where these units are located.
Healthcare providers and patients should contact Carl Zeiss Meditec AG for instructions on how to address the software issue. The source text does not provide specific consumer action steps beyond the recall notice itself, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the…
- Manufacturer
- Carl Zeiss Meditec AG
- Hazard
- Affected units
- 1,882
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Softwre versions 7.5 and 7.7
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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