MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISULAS COMBI; LASER, OPHTHALMIC

Catalog Number	000000-2730-493
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
The most possible root cause cannot be determined based on the available information.Further investigation is required.
Additional Manufacturer Narrative
Description of changes: field b4: added "date of this report" 02/20/2026.Field g3: updated "date received by manufacturer" to "02/12/2026".Field g6: checked "30 days", updated to "follow-up, # 1".Field h2: checked "device evaluation" and "additional information".Field h3: updated "device evaluated by manufacturer?" to "yes".Field h6: added "type of investigation" code 10, added "investigation findings" code 213, added " investigation conclusion" code 50.Field h11: added description of changes.It turned out that in this case atherosclerosis, a pre-existing condition of the patient, was the cause for the loss of consciousness and the seizure.There is no information that reasonably suggests that there was a malfunction of the zeiss device that could have contributed to the reported event.Arteriosclerosis is in no way related to the treatment with the visulas.

• Brand Name: VISULAS COMBI
• Common Device Name: LASER, OPHTHALMIC
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); goeschwitzer-strasse 51-52; jena, thueringia 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); goeschwitzer-strasse 51-52; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 23560960
• Report Number: 9615030-2025-00021
• Device Sequence Number: 15981121
• Product Code: HQF
• UDI-Device Identifier: 04049471091496
• UDI-Public: (01)04049471091496(11)250301
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K233911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 000000-2730-493
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown