VISULAS green (UDI 04049471091441)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 a dual fiber port. The laser console with dual fiber port forms part of both models, VISULAS green classic and VISULAS green comfort. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049471091441), received between Sep 26, 2024 and Oct 24, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Use of Device Problem1
Patient problems
- Intraocular Pressure Increased2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PRIMARY OPEN-ANGLE GLAUCOMA (POAG) PATIENT SUFFERED FROM A PERSISTING INCREASE IN INTRAOCULAR PRESSURE (IOP) AFTER SELECTIVE LASER TRABECULOPLASTY (SLT) TREATMENT. IT WAS FURTHER REPORTED THAT THE NUMBER OF GLAUCOMA MEDICATIONS HAD TO BE INCREASED FROM 2 TO 3.
Patient problems: Intraocular Pressure Increased
MAUDE report 20526971 ↗InjurySep 26, 2024Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT A PATIENT SUFFERED FROM UNCONTROLLABLE RISE OF INTRAOCULAR PRESSURE (IOP) AFTER SELECTIVE LASER TRABECULOPLASTY (SLT) TREATMENT. WHILE A TRANSIENT IOP RISE IS A COMMON SIDE EFFECT, THIS SPECIFIC PATIENT NEEDED AN INCREASE OF MEDICATION (FROM ONE DRUG TO TWO) DUE TO INSUFFICIENT IOP CONTROL AFTER THE SPIKE. THREE MONTHS AFTER LASER TREATMENT THIS PATIENT NEEDED A SURGERY BECAUSE OF UNCONTROLLED IOP AND INABILITY FOR FURTHER INCREASE OF TOPICAL MEDICATION DUE TO MULTIPLE DRUGS INTOLERANCES. THE SURGERY PERFORMED WAS AN UNEVENTFUL PHACO-MIGS. THE IOP AT SIX MONTHS LASER TREATMENT FOLLOW UP WAS 12 MM HG (BASELINE IOP OF 29 MMHG)
Patient problems: Intraocular Pressure Increased
MAUDE report 20311563 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.