MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT EX500 EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990794

Device Problem Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A doctor reported mild difficulty acquiring the pupil for tracking at the beginning of treatment but was able to engage it and proceed with treatment.In the middle of the case the eye tracker suddenly lost the pupil and the treatment was interrupted.After multiple attempts to recapture the pupil were unsuccessful, the doctor evaluated the steadiness of the patient's gaze and decided to turn off the eye tracker for the remainder of the case.Once the eye tracker was turned off, the laser treatment was continued without further incident.The patient's gaze remained steady throughout the case.

Manufacturer Narrative

A review of the device history record (dhr) traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.Review of the logfile for the day of treatment shows during the start-up in the morning the system passed all initialization steps without any relevant deviation.The user skipped the gas change, skipped the scanner test and performed the necessary energy check, eyetracker and fluence test without any issue.The logfile shows multiple successfully performed treatments.The energy was stable during the whole day.The treatment could be identified.During laser awarning message occurred.User switched eyetracker off an completed treatment successfully without further interruption.The reported issue could be confirmed.No technical root cause could be identified via logfile review.As mentioned in initial report description there were several contributing factors like small pupil size and the doctor blocked one of the infrared light pods with his hand partially, which contributes to the reported issue.Without enough infrared (ir) light the eyetracker cannot work.The most possible root cause is user handling as doctor blocked ir light with his hand during laser firing.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 10828724
• MDR Text Key: 217433021
• Report Number: 3003288808-2020-00708
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 25 YR