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Oculus Optikgeraete GMBH FDA Recalls
6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Oculus Pentacam AXL , Ref 70100, CE 0123Class IIAug 8, 2023Their is a potential that optical devices with insufficient |
| Oculus Pentacam AXL Wave, Ref 70020, CE 0123Class IIAug 8, 2023Their is a potential that optical devices with insufficient |
| Oculus Myopia Master , Ref 68100, CE 0123Class IIAug 8, 2023Their is a potential that optical devices with insufficient |
| Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.Class IIJul 8, 2022Due to a software issue, IOL calculator printout often does |
| Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.Class IIJul 8, 2022Due to a software issue, IOL calculator printout often does |
| Pentacam HR REF 70900. Used to image the anterior segment of the eye.Class IIJul 8, 2022Due to a software issue, IOL calculator printout often does |