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

Catalog Number 8065990794

Device Problem Poor Quality Image (1408)

Patient Problem No Code Available (3191)

Event Date 05/17/2018

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 clinical application specialist reported that during a wave front optimized refractive procedure, a patient's right eye treatment was decentered.When treatment report was analyzed there was no record of eye tracking by the eye tracker and images captured were of very low quality.Upon follow up, treatment was able to be completed the same day.Patient is being reviewed every month and waiting for corneal stability to plan retreatment guided by topography.

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company¿s acceptance criteria.At the visit on site after this complaint, the field service engineer verified the system successfully according to company specifications.No abnormalities were found which could have contributed to the event.Review of the logfile showed no errors, warnings and no technical abnormalities for the complete treatment day.Against the statement of the reporter, the eye tracker was on during the complete treatment.There is no indication a device malfunction caused or contributed to the reported event.No technical root cause was identified as the product was found to be within specifications.The root cause cannot be determined conclusively.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: 7654274
• MDR Text Key: 113183797
• Report Number: 3003288808-2018-01202
• 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
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 8065990794
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other