Oculus Optikgeraete recalls

2 official recalls and safety alerts involving Oculus Optikgeraete since 2022-09, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Oculus Optikgeraete or the relevant agency.

1. 2023-09-06
2. US
   Drugs & medicalClass II

   Oculus Optikgeraete GMBH recalls Oculus Pentacam AXL , Ref 70100, CE 0123

   Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.

   FDA · DeviceOculus Optikgeraete GMBHUS Nationwide distribution in the states of CA, FL, MA, MN, NY, NC, OH, PA,…Official notice →
3. 2022-09-07
4. US
   Drugs & medicalClass II

   Oculus Optikgeraete GMBH recalls Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.

   Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

   FDA · DeviceOculus Optikgeraete GMBHU.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN,…Official notice →