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

Catalog Number 8065990794

Device Problem Overcorrection (3006)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2020

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.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported an overcorrection post custom lasik on a patient's left eye.There are multiple related reports for this facility.This report addresses the patient eg's left eye and other manufacturer reports will be filed.

Manufacturer Narrative

Device history records (dhr) for the device was reviewed.The associated device was released based on company's acceptance criteria.Review of the logfile for the day of treatment showed during the start-up in the morning, the system passed all initialization steps without any relevant deviation.The user performed the gas change, skipped the scanner test and performed the necessary energy check, eyetracker and fluence test without any issue.The logfile showed a couple of successfully performed treatments.The user performed an energy check before this patient.The energy was stable during the whole day.The corresponding treatment was performed without interruption.No abnormalities or deviations could be detected in the logfiles which could contribute the reported issue.The root cause could not be identified by the investigation.According to logfile review, the device was working as intended.No technical root cause could be identified.The manufacturer internal reference number is: 2020-17160.

• 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: 9924365
• MDR Text Key: 187087937
• Report Number: 3003288808-2020-00276
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WAVELIGHT FS200
• Patient Outcome(s): Other
• Patient Age: 22 YR