MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE EYE-Q EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990739

Device Problem Failure to Deliver Energy (1211)

Patient Problem Visual Impairment (2138)

Event Date 11/01/2018

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.No udi required due to this device being out of production prior to the september 24, 2014 udi regulation date.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported the laser stopped mid treatment at forty eight percent.The site performed a gas change and were able to complete the procedure.The field service engineer reported the treatment was restarted from the beginning resulting in the patient being over corrected.Additional information has been requested.

Manufacturer Narrative

A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to the day of the treatment.The logfile review confirmed treatment was interrupted at 48%.An energy error message was displayed and the treatment was interrupted.The device was shut down and restarted.During starting the device several energy checks were performed.The energy was stable.The surgeon restarted the treatment and the treatment was finished to 100% without any further messages.The root cause could not be identified conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALLEGRETTO WAVE EYE-Q EXCIMER LASER
• Type of Device: OPHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• MDR Report Key: 8079105
• MDR Text Key: 127423218
• Report Number: 3003288808-2018-01835
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990739
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other