VISULAS green (UDI 04049471091434)Recalls & reported problems
Carl Zeiss Meditec AG · VISULAS green is intended for use in photocoagulation of tissues in the posterior and anterior segments of the eye including trabeculoplasty and iridotomy. The DI number characterizes the laser console which has one single fiber port. The laser console with single fiber port forms part of both models, VISULAS green classic and VISULAS green comfort. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049471091434), received between Mar 17, 2025 and Mar 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- Corneal Clouding/Hazing1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 17, 2025Off-Label Use; Off-Label Use
CARL ZEISS MEDITEC AG IN JENA WAS MADE AWARE BY ITS SSC (SALES AND SERVICE COMPANY) IN POLAND THAT A CUSTOMER USED VISULAS GREEN FOR TRANSPUPILLARY THERMOTHERAPY (TTT) TO TREAT CANCER TISSUE IN TWO PATIENTS. IN ONE OF THESE PATIENTS, THE CORNEA TURNED CLOUDY RIGHT AFTER TREATMENT. TRANSPUPILLARY THERMOTHERAPY IS NOT PART OF VISULAS GREEN INTENDED USE.
Patient problems: Corneal Clouding/Hazing
MAUDE report 21627570 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.