Oculus Optikgeraete recalls Pentacam AXL REF 70100 and HR REF 70900 ophthalmic imaging devices due to software errors affecting IOL alignment calculations.
Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
Oculus Optikgeraete is recalling Pentacam AXL REF 70100 and HR REF 70900 eye imaging devices. The software issue may cause inaccurate IOL alignment calculations for cataract surgery planning, potentially leading to incorrect surgical outcomes.
The software version 1.26r26 and 1.26r27 has a known issue where IOL calculator printouts do not accurately show the alignment axis and incision position. This could lead to incorrect surgical planning for toric IOLs, which are specialized lenses for correcting astigmatism.
Eye care professionals using Pentacam AXL REF 70100 or HR REF 70900 devices for cataract surgery planning. Patients undergoing IOL implantation may be at risk of incorrect surgical outcomes.
Check for the model numbers 70100 (AXL) or 70900 (HR) with software versions 1.26r26 or 1.26r27. The devices were sold with serial numbers listed in the recall notice.
Verify the software version on your device; if it is 1.26r26 or 1.26r27, it is affected.
The software version 1.26r26 and 1.26r27 has a known issue where IOL calculator printouts do not accurately reflect the alignment axis and incision position for toric IOLs.
The recall does not specify a remedy; check the software version and contact Oculus Optikgeraete for further instructions.
The recall indicates a potential for incorrect surgical outcomes but does not mention injury risks to users.
We’ve drafted a message you can send Oculus Optikgeraete to request your refund or repair — edit it as you like.
Subject: Recall Z-1673-2022 — Oculus Optikgeraete Oculus Optikgeraete Hello, I own a Oculus Optikgeraete that is covered by recall Z-1673-2022 from Oculus Optikgeraete. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
