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

Catalog Number	000000-1345-518
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A difficult case was reported with a substandard outcome for one patient od.Original treatment was a smile attempt with suction loss in the posterior cut.Surgeon proceeded with a flap repair cut, lifted the flap and treated with an excimer laser.The patient's vision was reported to be 20/150, however, it was not shared if this was uncorrected vision or best corrected vision.Thus, it is unclear whether there was a negative impact on this patient.It cannot be determined whether the patient has lost more than 2 lines of the best corrected visual acuity (bcva).
Additional Manufacturer Narrative
The most possible root cause is a user error.Most probably, due to the interruption of the initial smile surgery, the cornea became dehydrated.Thus, the subsequent flap was performed on a very dehydrated cornea and the flap was thicker than planned so that, during the ablation with the excimer laser, the smile lenticule interface was reached.This smile interface can then move as loose lamellar structure resulting in an irregular corneal topography with reduced visual acuity.There is no information that reasonably suggests that there was a malfunction of the zeiss device that could have contributed to the complained unexpected surgical outcome.

• 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
• MDR Report Key: 21936889
• Report Number: 9615030-2025-00010
• Device Sequence Number: 5228990
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)201201
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P150040
• 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): 04/30/2025

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: 000000-1345-518
• 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: 04/01/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2020
• 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