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

Catalog Number 8065990713

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 03/23/2017

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

An ophthalmologist reported a planning error in case with axis deviations greater than 15 degrees between topography and cylinder measured.There are multiple related reports for this facility.This report addresses patient four's left eye and other manufacturer reports will be filed.

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.The system history shows no abnormalities that could have contributed to this event.The review shows that the laser was successfully verified prior to and after the date of event/treatment.Clinical investigation on site revealed that cylinder was not included in treatment plan- reason for retreatment.Used wrong protocol for treatment planning.The root cause for the reported planning error was a planning issue in regards to the treated astigmatism value.Apparently, the user was following a wrong protocol and therefore, the cylinder was not treated.Thus, the planned treatments lead to an undercorrection of the cylinder (cause it wasn't treated) which would require retreatment of some patients.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: 7777015
• MDR Text Key: 116906242
• Report Number: 3003288808-2018-01459
• 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: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR