Carl Zeiss Meditec recalls IOLMaster 700 devices with serial number 1185393 due to incorrect calibration causing inaccurate eye imaging. Affected units may provide wrong measurements for eye surgery planning.
Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
Carl Zeiss Meditec is recalling one IOLMaster 700 device (serial number 1185393) because its calibration setting was entered incorrectly during manufacturing. This could lead to inaccurate eye measurements used in cataract surgery planning, potentially affecting surgical outcomes.
The device's calibration setting was incorrectly entered during manufacturing, causing it to produce inaccurate two-dimensional images of the eye's anterior and posterior segments. This could lead to incorrect measurements for cataract surgery planning, potentially affecting surgical outcomes.
Ophthalmologists and eye care professionals who use the IOLMaster 700 device for eye measurements. The risk is highest for those who rely on this specific device for surgical planning.
Check for the serial number 1185393 on the device. The affected unit was manufactured on September 1, 2017, with reference number 1932-169.
Look for the serial number 1185393 on the IOLMaster 700 device.
The recall is due to potential inaccurate eye measurements, not immediate danger to the eye. The device may provide incorrect measurements for cataract surgery planning.
Check the serial number on the device; if it is 1185393, it is affected. The device was manufactured on September 1, 2017, with reference number 1932-169.
The recall does not specify a remedy, so contact Carl Zeiss Meditec directly for guidance.
We’ve drafted a message you can send Carl Zeiss Meditec to request your refund or repair — edit it as you like.
Subject: Recall Z-0108-2019 — Carl Zeiss Meditec Carl Zeiss Meditec Hello, I own a Carl Zeiss Meditec that is covered by recall Z-0108-2019 from Carl Zeiss Meditec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
