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

Catalog Number 8065990794

Device Problem Incorrect Measurement (1383)

Patient Problem No Code Available (3191)

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

Event Description

A facility representative reported a patient with a possible unexpected outcome.The patient had treatment when the eye tracker adjustments were not measuring accurately.Additional information has been requested.

Manufacturer Narrative

During on site visit, field service engineer (fse) reset tracker to zero.Completed system verification to specification.The root cause can not 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: 9544959
• MDR Text Key: 173718422
• Report Number: 3003288808-2020-00007
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• 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?: Yes
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other