Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Oculus Optikgeraete GmbH with 7 device recalls. The most recent is a device recall dated Aug 8, 2023: Oculus Pentacam AXL , Ref 70100, CE 0123.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 8, 2023 | Oculus Pentacam AXL , Ref 70100, CE 0123Class II · Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length | Device recalls |
| Aug 8, 2023 | Oculus Myopia Master , Ref 68100, CE 0123Class II · Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length | Device recalls |
| Aug 8, 2023 | Oculus Pentacam AXL Wave, Ref 70020, CE 0123Class II · Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length | Device recalls |
| Jul 8, 2022 | Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.Class II · Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision posit | Device recalls |
| Jul 8, 2022 | Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.Class II · Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision posit | Device recalls |
| Jul 8, 2022 | Pentacam HR REF 70900. Used to image the anterior segment of the eye.Class II · Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision posit | Device recalls |
| Nov 21, 2017 | OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS OptikgeratClass II · The device software versions have an anomaly which may produce an erroneous marking for the quality specification value | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
