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

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during treatment, flap was created but it appeared that there was no hinge when lifted.Cap completely came off.
Additional Manufacturer Narrative
Based on the available information and device evaluation there was no device malfunction.In addition, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design or labeling.The root cause is unknown.It can be assumed that the likely root cause is user error.

• 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 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: 24811483
• Report Number: 9615030-2026-00017
• Device Sequence Number: 12268748
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: 010404947109503611190301
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P150040 S020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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 Model Number: N/A
• Device Catalogue Number: 000000-2177-848
• Device Lot Number: N/A
• 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: 03/10/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2019
• 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; Death
• Patient Sex: Unknown