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Oculus Optikgeraete Recalls
7 recalls on record · February 28, 2018 to September 6, 2023 · Medical Devices
Recalls by year
18
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 6, 2023Medical DevicesFDA
Oculus Optikgeraete GMBH recalls Oculus Myopia Master , Ref 68100, CE 0123
Hazard: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
September 6, 2023Medical DevicesFDA
Oculus Optikgeraete GMBH recalls Oculus Pentacam AXL , Ref 70100, CE 0123
Hazard: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
September 6, 2023Medical DevicesFDA
Oculus Optikgeraete GMBH recalls Oculus Pentacam AXL Wave, Ref 70020, CE 0123
Hazard: Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
September 7, 2022Medical DevicesFDA
Oculus Optikgeraete GMBH recalls Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Hazard: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
September 7, 2022Medical DevicesFDA
Oculus Optikgeraete GMBH recalls Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
Hazard: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
September 7, 2022Medical DevicesFDA
Oculus Optikgeraete GMBH recalls Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
Hazard: Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs
February 28, 2018Medical DevicesFDA
Oculus Optikgeraete GMBH recalls OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label
Hazard: The device software versions have an anomaly which may produce an erroneous marking for the quality specification value