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

Model Number 8065990631

Device Problem Failure to Sense (1559)

Patient Problem No Information (3190)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

A customer reported that pupil detection worked correctly during testing but not on human eye.According to the reporter, the event was a centering issue and pupil detection issue.Eyetracking was reported to move from one day to the next only on human eye.The customer reported that several technical interventions were managed for the laser with a change of system board etc.Between (b)(6) 2014 and no visible reason was found.The laser was put in quarantine on (b)(6) 2015.This is one of three med device reports being filed for this facility.This report is for the pupil detection issues.

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 info becomes available.Additional info 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 s freeway; r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4510853
• MDR Text Key: 21770416
• Report Number: 3003288808-2015-00102
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030008/P02
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2007
• 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