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

Catalog Number 8065990794

Device Problems Incorrect Measurement (1383); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/26/2019

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.Device history record (dhr) for the device was reviewed.The associated device was released based on company's acceptance criteria.The manufacturer internal reference number is: (b)(4).

Event Description

A risk manager reported a patient underwent topoguided lasik.Treatment error was discovered at one week post operative visit.Axis of 090 was entered instead of 12.Surgeon entered treatment from nomogram tool and not the measured axis.Patient was retreated.

Manufacturer Narrative

Logfile review showed the reported treatment could be identified in the logfile.The system was working within specification as intended.A technical root cause could be excluded.Clinical applications specialist review showed a massive axis input error and non-application of the recommended protocol for the left eye.Therefore, the reported treatment error could be confirmed and caused by wrong typing of axis value.The root cause is user error.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: 8443333
• MDR Text Key: 139547316
• Report Number: 3003288808-2019-00323
• 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: 03/04/2019,07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• 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: 02/05/2019
• Device Age: 4 YR
• Event Location: Other
• Date Report to Manufacturer: 03/04/2019
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR