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

Model Number	VISUMAX
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The most possible root cause is a user error.There was too much liquid on the eye.As a consequence, the lenticule cut on the upper part is not sharp and not clearly defined which explains the difficult dissection.There is no indication that there was a malfunction of the zeiss device that contributed to the complications during lenticule removal.With the current information, there is no indication of any malfunction of the zeiss device which could have contributed to the reported surgical outcome.
Event or Problem Description
It was reported by the surgeon that there was a complication with a lenticule removal, and sticky dissection.Lenticular interface was extremely sticky ; one quarter of side cut appeared to be missing.The doctor mentioned an injury: irregular astigmatism on patient cornea.

• Brand Name: VISUMAX FEMTOSECOND LASER
• 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 hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 17997105
• Report Number: 9615030-2023-00008
• Device Sequence Number: 17603968
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)210101
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2023

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: VISUMAX
• 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: 09/25/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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