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

Model Number	VisuMax
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Corneal Scar (1793); Eye Injury (1845); Visual Impairment (2138)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon reported that the patient developed a buttonhole paracentral to the visual axis which has resulted in a small stromal scar.Evaluation of the treatment video showed that the reported scar was a result of repeated suction loss and the immediate restart of the procedure with a dirty surface of the used treatment pack.The consequence of the dirty surface was an incomplete cut followed by manipulations during lenticule extractions that eventually caused the stromal scar.An assessment of visual acuity of the patient can only be made cautiously based on the available data.Currently, there is a loss of visual acuity and the patient notes an opacity that has continued to be monitored.
Additional Manufacturer Narrative
Based on the available information, the most possible root cause is user error as the surgeon continued the laser treatment although there was clearly visible foreign material on the patient's eye which caused an incomplete cut.Despite the incomplete cut, the doctor dissected the lenticule thereby causing a stromal trauma due to the tough dissection.

• 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: 15597276
• Report Number: 9615030-2022-00007
• Device Sequence Number: 2277866
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)210101
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 10/13/2022

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: 09/27/2022
• Initial Report FDA Received Date: 10/13/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 49 YR
• Patient Sex: Female