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Tracey-VFA Visual Function Analyzer
TRACEY TECHNOLOGIES, CORPORATION · Model iTrace · UDI-DI 00860479001706
4
510(k) clearances
649
Adverse events
2
Recalls
11
Facilities
Description
The iTrace is used to measure the refractive, wavefront and corneal topographic data of the human optical system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-06-30 | Alcon Research, Ltd. | Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that resul |
| 2017-06-30 | Alcon Research, Ltd. | Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that resul |
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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.