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VISUPAC 500

Carl Zeiss Meditec AG · Model VISUPAC 500 · UDI-DI 04049471094077

NFGNFF
0
510(k) clearances
39
Adverse events
1
Recalls
18
Facilities

Description

The VISUPAC digital image capturing and archiving system is intended for capturing, displaying and storing images of the retina and surrounding area of the eye. These photographs support the diagnosis and progress monitoring of eye diseases which can be visually monitored and photographically documented.

Recalls

DateFirmReason
2016-03-01Alcon Research, Ltd.Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after receiving reports c

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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.