Home › Alcon Laboratories, Inc. › ORA System® VerifEye™
ORA System® VerifEye™
Alcon Laboratories, Inc. · Model 8065998328 · UDI-DI 00380659983283
NCF
Prescription
4
510(k) clearances
649
Adverse events
2
Recalls
11
Facilities
Description
ORA System with VerifEyeTM+, Aberometer 190.5
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.