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ORA System® VerifEye™

Alcon Laboratories, Inc. · Model 8065753093 · UDI-DI 00380657530939

NCF Prescription
4
510(k) clearances
652
Adverse events
2
Recalls
11
Facilities

Description

ORA System with VerifEyeTM+ 2.0, Cart

Recalls

DateFirmReason
2017-06-30Alcon 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
2017-06-30Alcon 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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Data 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.