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

Catalog Number 8065990713

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Dry Eye(s) (1814); Irritation (1941); Increased Sensitivity (2065)

Event Date 08/29/2019

Event Type  Injury  

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 customer reported an eye tracker error.Additional information received states that the eye tracker error occurred two seconds after the laser fired during sub-bowman's keratomileusis in the right eye.The treatment was stopped and the laser was shut down, rebooted and recalibrated.The patient's flap was repositioned and the eye was kept closed during calibration.Treatment was resumed and completed.The patient was noted to have mild light sensitivity, dryness, and increased irritation at one day follow up.No treatment needed and the patient will continue to be monitored.

Manufacturer Narrative

The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.During on site visit, the field service engineer(fse) replaced the pc, eye-tracker pcb board and some optics were replaced to improve energy levels.Full service test procedure.Review of the logfile for the day of treatment shows no error messages or warnings.During the start-up in the morning the system passed all initialization steps without any relevant deviation.The user performed the gas change, performed the scanner test and performed the necessary energy, eye tracker and fluence test without any issue.The review of the complete day confirmed an error message displayed.This error message occurred before laser fired.The laser was restarted and the treatment was performed successfully without interruption.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The root cause could be determined conclusively as an error of complex programmable logic device.This leads to a sporadically missing signal send from the eye tracker to the system, so that the system could not find the eye tracker components and an eye tracker time out occurred.The manufacturer internal reference number is: 2019-81024.

• 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: 9481063
• MDR Text Key: 171632111
• Report Number: 3003288808-2019-01244
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR