Oculus recalls Pentacam AXL Wave REF 70020 devices due to software issues causing inaccurate IOL alignment calculations for toric intraocular lenses.
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 AXL Wave REF 70020 devices because their software sometimes produces incorrect measurements for toric IOL planning. This could lead to improper lens placement during eye surgery, potentially affecting surgical outcomes.
The software version 1.26r26 and 1.26r27 may not correctly display the alignment axis and incision position when calculating toric IOLs. This could result in improper lens placement during cataract surgery, potentially affecting visual outcomes.
Eye surgeons and patients using the Pentacam AXL Wave REF 70020 devices for pre-surgical eye imaging. Those planning toric intraocular lenses are most at risk of inaccurate surgical measurements.
Check for the model number 70020 with serial numbers starting with 70020 followed by 4 digits (e.g., 70020 0111 0201). Devices sold with software versions 1.26r26 or 1.26r27 are affected.
Verify your device's software version is 1.26r26 or 1.26r27 by checking the device settings or documentation.
Reach out to Oculus Optikgeraete GMBH directly for assistance with the recall process.
The device may produce inaccurate measurements for toric IOL planning, but it is not immediately dangerous. Users should check the software version and contact Oculus for guidance.
Check for the model number 70020 with serial numbers starting with 70020 followed by 4 digits, and software versions 1.26r26 or 1.26r27.
Contact Oculus Optikgeraete GMBH directly for assistance with the recall process.
We’ve drafted a message you can send Oculus to request your refund or repair — edit it as you like.
Subject: Recall Z-1672-2022 — Oculus Oculus Hello, I own a Oculus that is covered by recall Z-1672-2022 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.
