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Myopia Master
OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Model 68130 · UDI-DI 04049584029959
MXK
Prescription
1
510(k) clearances
12
Adverse events
7
Recalls
18
Facilities
Description
The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-08 | Oculus Optikgeraete GMBH | Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. |
| 2023-08-08 | Oculus Optikgeraete GMBH | Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. |
| 2023-08-08 | Oculus Optikgeraete GMBH | Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements. |
| 2022-07-08 | Oculus Optikgeraete GMBH | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs |
| 2022-07-08 | Oculus Optikgeraete GMBH | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs |
| 2022-07-08 | Oculus Optikgeraete GMBH | Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs |
| 2017-11-21 | Oculus Optikgeraete GMBH | The device software versions have an anomaly which may produce an erroneous marking for the quality specification value |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.