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

Catalog Number	000000-2096-101
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Corneal Clouding/Hazing (1878)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been regularly serviced by zeiss.The last preventive maintenance was performed by a zeiss fse on (b)(6) 2025.No safety or functional deficiencies were detected; functional checks successfully completed.The customer themself did not report or complain any device malfunction related to the performed surgery.There is no allegation of a device problem on the day of surgery.According to the instruction for use, the device is intended only for photocoagulation of the retina, trabeculoplasty for treatment of glaucoma, iridotomy for treatment of glaucoma and use in selective laser trabeculoplasty (slt).In this case, the user performed transpupillary thermotherapy (ttt) with a visulas green which represents an off-label use.There is no information that reasonably suggests that there was a malfunction of the visulas green that could have contributed to the surgical outcome.The manufacturer has become aware of information that reasonably suggests that off-label usage of the visulas green may have caused or contributed to the reported event.
Event or Problem Description
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.
Additional Manufacturer Narrative
Update: it was confirmed that the patients treated with this off-label method are doing well and do not require any additional medical intervention.

• Brand Name: VISULAS GREEN COMFORT
• Common Device Name: LASER, OPHTHALMIC
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 07745 ; GM 07745
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 21627570
• Report Number: 9615030-2025-00002
• Device Sequence Number: 8331401
• Product Code: HQF
• UDI-Device Identifier: 04049471091434
• UDI-Public: (01)04049471091434(11)231101
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K181682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: 000000-2096-101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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: Other
• Patient Sex: Unknown