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

Model Number VisuMax

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Corneal Scar (1793); Eye Injury (1845); Visual Impairment (2138)

Event Date 06/24/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 301666289
• Report Number: 9615030-2022-00007
• Device Sequence Number: 1
• Product Code: OTL
• UDI-Device Identifier: 04049471095036
• UDI-Public: (01)04049471095036(11)210101
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 49 YR
• Patient Sex: Female