MAUDE Adverse Event Report: TECHNOLAS PERFECT VISION GMBH VICTUS Femtosecond Laser Platform

Model Number	14000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026 the surgeon reported a capsulotomy tag that lead to a tear.On (b)(6) 2026 additional information was received.The surgeon confirmed that parts of the crystalline lens dropped into the vitreous, and that the patient has been referred to another clinic (this is the awareness date).After further inquiry on (b)(6) 2026 we received the information that the patient had the lens fragments removed and a posterior vitrectomy was performed.

• Brand Name: VICTUS Femtosecond Laser Platform
• Common Device Name: VICTUS Femtosecond Laser Platform
• Manufacturer (Section D): TECHNOLAS PERFECT VISION GMBH; messerschmittstr 1+3; munchen, bavaria 80992 DE; GM 80992 DE
• Manufacturer (Section G): TECHNOLAS PERFECT VISION GMBH; messerschmittstr 1+3; munchen, bavaria 80992 DE; GM 80992 DE
• Manufacturer Contact: friedrich moritz ; messerschmittstr 1+3; munchen, bavaria 80992- DE ; GM 80992 DE
• MDR Report Key: 50851380
• Report Number: 3003691824-2026-00001
• Device Sequence Number: 9953297
• Product Code: OOE
• UDI-Device Identifier: 04050555002895
• UDI-Public: 04050555002895
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 14000
• Device Catalogue Number: 14000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2015
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown