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ORA System® VerifEye™
Alcon Laboratories, Inc. · Model 8065998330 · UDI-DI 00380659983306
NCF
Prescription
4
510(k) clearances
649
Adverse events
2
Recalls
11
Facilities
Description
ORA System with VerifEye + Technology , Abberometer 195.5mm Transient, non-invasive, active therapeutic device, intended for diagnosis and monitoring in ophthalmic surgical procedure.
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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