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

Model Number 8065990713

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem No Information (3190)

Event Date 07/21/2014

Event Type  Injury  

Event Description

A healthcare professional reported that a system message indicating an excessive laser output was displayed at 78% of a lasik surgery.The system was restarted and a second system message was displayed.The treatment was not completed.Patient status was unk at the time this report was prepared.Additional info has been requested but not received to date.

Manufacturer Narrative

The device was received by a co rep and is in transit to the mfg site for investigation.A service visit was performed.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 info becomes available.Additional info has been requested but not received to date.(b)(4).

• Brand Name: WAVELIGHT EX500 EXCIMER LASER
• Type of Device: PHTHALMIC EXCIMER LASER SYSTEM
• Manufacturer (Section D): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 9105 8; GM 91058
• Manufacturer Contact: janet moran ; 6201 south freeway r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4023984
• MDR Text Key: 4844615
• Report Number: 3003288808-2014-01253
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P030008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065990713
• Device Catalogue Number: 8065990713
• Other Device ID Number: SP2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other