MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) VISUMAX; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The most possible root cause cannot be determined based on the available information.There is no information and there are no indications that reasonably suggests that there was a malfunction of the visumax device that could have contributed to the reported too thin and torn flap os.A number of factors not related to the device may have influenced the treatment outcome.Not all are controlled by the manufacturer.
Event or Problem Description
The manufacturer received an anonymous notification through brazilian authority anvisa, in which the client reported that the device displayed a error message when a flap treatment should be started and the system was shut off.The client had to restart the equipment to attempt the procedure again.After rebooting, no error message appeared, and they were able to perform the procedure on the first eye (od) successfully.For the second eye, there was no error message either, but the flap turned out too thin and ended up tearing.As a result, client decided to abort the procedure on the second eye.

• Brand Name: VISUMAX
• Common Device Name: FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (JENA); carl zeiss promenade 10; jena, thueringia 7745 ; GM 7745
• Manufacturer Contact: manjaya manjaya ; 5300 central parkway; dublin, CA 94568 ; 9255574259
• MDR Report Key: 22312084
• Report Number: 9615030-2025-00015
• Device Sequence Number: 8988161
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)150301
• Combination Product (Y/N): N
• PMA/510(K) Number: P150040 S018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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 Model Number: N/A
• Device Catalogue Number: 000000-1345-518
• 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: 05/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2015
• 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