Oculus recalls Pentacam HR REF 70900 for potential inaccurate IOL alignment calculations due to software version 1.26r26 and 1.26r27. Affected devices may lead to incorrect surgical planning for toric IOLs.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Oculus is recalling Pentacam HR REF 70900 devices because their software versions 1.26r26 and 1.26r27 can produce inaccurate IOL alignment calculations. This could lead to incorrect surgical planning for toric intraocular lenses, potentially affecting eye surgery outcomes.
The software issue causes the IOL calculator printout to often not accurately reflect the alignment axis and incision position when planning toric intraocular lenses. This could lead to incorrect surgical planning, potentially affecting the outcome of eye surgery.
Eye surgeons and ophthalmologists who use Pentacam HR REF 70900 devices with software versions 1.26r26 or 1.26r27 are most at risk. Patients receiving toric IOL surgery may be affected if the device's calculations are inaccurate.
Check for the model number 70900 with software versions 1.26r26 or 1.26r27. Devices sold between 2019 and 2023 are likely affected based on the serial numbers provided.
Verify your Pentacam HR device's software version; affected units have versions 1.26r26 or 1.26r27.
No, the recall does not require stopping use. The issue is with software versions that may produce inaccurate calculations, but the device can still be used safely with updated software.
The recall record does not specify software updates or remedies, so no action is required beyond checking the software version.
Inaccurate calculations could lead to incorrect surgical planning for toric IOLs, but the recall does not provide details on specific consequences.
We’ve drafted a message you can send Oculus to request your refund or repair — edit it as you like.
Subject: Recall Z-1674-2022 — Oculus Oculus Hello, I own a Oculus that is covered by recall Z-1674-2022 from Oculus. 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.
