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

Catalog Number 8065990794

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Visual Impairment (2138)

Event Date 01/16/2017

Event Type  Injury  

Manufacturer Narrative

The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.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 risk manager reported a patient underwent lasik in both eyes for monovision.An error was made during treatment calculation and the dominant eye (right eye) was treated for near and the non dominant eye (left eye) was treated for distance.The patient has been trying to adapt but is unable.The patient is trialing soft contact lenses in the right eye and if successful an enhancement will be scheduled.There are two related reports for this patient.This report addresses the patient's left eye, and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

Logfile review for the day of treatment shows all laser system functions were within specifications for the respective treatment.The system passed successfully all initialization steps.The user performed a gas change, performed the scanner test and performed the needed energy check, eyetracker test and fluence test without any issue.The logfile shows 31 successfully performed treatments.The energy was stable during the whole day.The user performed an energy check before this patient.The corresponding treatment was performed without interruption.No abnormalities or deviations can be detected in the logfiles, which can contribute the reported issue.According to the report the right eye has been treated with the wrong refraction.The doctor treated a monovision with the right eye (dominant) for near and the left eye for distance vision.No technical failure can be identified by reviewing the logfile.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: 8552552
• MDR Text Key: 143211214
• Report Number: 3003288808-2019-00447
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2019,06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990794
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2019
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 03/29/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR