Reported Dec 9, 2015 · Terminated
IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations…
Carl Zeiss Meditec AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Carl Zeiss Meditec AG · Carl Zeiss Promenade 10 · Jena · N/A
Is this the product you have?
- IOL Master 5.5: Software versions 7.5 and 7.7
- Ophthalmicused to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation
- Lot codes and dates
- Software versions 7.5 and 7.7:
- Serial numbers
1040306104545010353121034011103531010431451039588104180510403211041803104544310367161035318103880010340161041838104183310395871035291104031310387951034051103655310403141036539103670210439521039614103654110431211036786103671310454551034801103479210340711043117103479510454511039611104394110366931041836103653210431321043134103407310348221040315
- Amount recalled
- 49
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
IOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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