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NGENUITY

Alcon Laboratories, Inc. · Model 00380650003997 · UDI-DI 00380650003997

FWJ Prescription
0
510(k) clearances
1
Adverse events
1
Recalls
7
Facilities

Description

Microsurgical Camera

Recalls

DateFirmReason
2024-05-23Alcon Research LLCAfter surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registrat

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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.