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

Catalog Number 000000-1345-518

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Edema (1791); Visual Impairment (2138); Insufficient Information (4580)

Event Date 04/24/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the doctor was working on a lasik procedure with visumax.After opening the flap the surgeon found an irregular cut in the stromal bed (central corneal island / button).The next procedure (eximer laser) was not continued.The patient was sent home.

Manufacturer Narrative

Investigation result summary: on march 28th, 2022, a flap procedure was performed on a patient with the visumax system.The corneal cutting procedure was interrupted during the flap cut and error 0x6122 was displayed on the visumax screen.The incision was not completed, and the patient was sent home.· an interruption of the treatment during a flap cut does not affect the visual acuity.There is no visual effect until tissue evaporates.Since in this case the flap was not lifted, and the inner corneal tissue was not reshaped by the excimer laser (tissue evaporates), there was no impact on the visual acuity of the patient.· in general, treatment interruption can happen due to different reasons e.G., suction loss, power failure, equipment malfunction or discomfort of the patient or doctor.An immediate restart of the surgery or a transformation to alternative excimer laser treatments can be helpful depending on the surgical step at which it occurs.Restart of flap treatment and aspects that require additional attention as well as further safety and warning instructions are described in the user manual (000000-1345-518-doks-fp-cz-1102141).· the displayed error 0x6122 indicates a scan control signal scan error.The device log file indicates that on the same day further flap surgeries have been completed successfully.A replacement of the scanner cable set by zeiss service on april 1st, 2022, solved this issue.On (b)(6) 2022, the patient was retreated.The laser settings were the same as for the first treatment in march.After opening the flap, the surgeon found significant irregularities in the central area of the cornea (central corneal island / button) and the subsequent procedure to reshape the cornea with the excimer laser was not carried out.The patient was sent home.· the described "central corneal button" can be assigned to the known side effect "disorders of cornea" and could cause visual impairments.A different cutting depth, e.G., due to regrowing epithelium, might have caused the described side effect.Our investigation has revealed that the initial flap treatment was interrupted by a scanner error and the patient was retreated with a flap treatment four weeks later, which is classified as a contraindication.The treatment should have been resumed immediately after the previous treatment phase was interrupted.A device inspection was performed.No safety or functional deficiencies were detected; functional checks successfully completed.According to the available information the root cause is a use error, which is neither due to ergonomic features, nor due to any inadequacy in the information supplied by the manufacturer.Section h6 - health effect clinical code: changed from 4580 (insufficient information) to 1791 (corneal edema); and 2138 (visual impairment); -health effect impact code: changed from 4648 (insufficient information), to 4610 (inadequate/inappropriate treatment or diagnostic exposure); 4635 unexpected deterioration; -type of investigation: added 10, testing of actual/suspected device; 4112 (analysis of data provided by user/third party); -investigation findings: changed from 3233 (results pending completion of investigation) to 4248, usage problem identified; 213, no device problem found; -investigation conclusions: changed from 11 (conclusion not yet available) to 19 (cause traced to user).

• 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: 14735554
• MDR Text Key: 294401409
• Report Number: 9615030-2022-00005
• Device Sequence Number: 1
• Product Code: OTL
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P150040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 000000-1345-518
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other