VISULAS VISULAS combiRecalls & reported problems
Carl Zeiss Meditec AG · VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including • Photocoagulation of the retina • Trabeculoplasty • Iridotomy • Posterior capsulotomy • Posterior membranectomy This device is Prescription Use (Rx) only. · 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 04049471091496), received between Nov 14, 2025 and Nov 14, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Convulsion/Seizure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT FOLLOWING A LASER TREATMENT WITH THE VISULAS COMBI ON A PATIENT IN CANADA, THE PATIENT APPARENTLY HAD A SEIZURE AND THE CLINIC CALLED A CODE BLUE. THE PATIENT HAS BEEN RELEASED; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. NOTE: IN THE CONTEXT OF A HOSPITAL IN CANADA, "CODE BLUE" REFERS TO A MEDICAL EMERGENCY SITUATION WHERE A PATIENT IS EXPERIENCING CARDIAC ARREST OR RESPIRATORY FAILURE AND REQUIRES IMMEDIATE RESUSCITATION. THIS TERM IS PART OF A STANDARDIZED SET OF EMERGENCY CODES USED IN HOSPITALS TO QUICKLY COMMUNICATE SPECIFIC TYPES OF EMERGENCIES TO STAFF.
Patient problems: Convulsion/Seizure
MAUDE report 23560960 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.