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

Model Number 8065990631

Device Problem Energy Spectrum Incorrect (1210)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

A customer reported system displayed system message of high voltage; eighty percent during procedure.Additional information from reporter indicated the procedure was completed with the same equipment and accessory, with no impact to patient.Additional information has been requested.

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.Additional information has been requested.(b)(4).

• Brand Name: ALLEGRETTO WAVE EYE-Q
• Type of Device: OPHTHALMIC 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: 4013971
• MDR Text Key: 20109368
• Report Number: 3003288808-2014-01067
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• PMA/PMN Number: P030008/P0
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8065990631
• Device Catalogue Number: 8065990631
• Other Device ID Number: V4-1.02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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