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

Catalog Number 8065990713

Device Problems Unstable (1667); Vibration (1674)

Patient Problem No Code Available (3191)

Event Date 08/31/2016

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.Additional information has been requested.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.(b)(4).

Event Description

A doctor reported deviations in astigmatism correction with spherical correction being good post lasik.The surgeon indicated that during multiple cases some treatment results are not satisfying since the demolition of a building near the hospital.Vibrations were noticeable in the operation room.Additional information has been requested.Multiple similar cases were reported, for which additional manufacturer reports will be submitted.

Manufacturer Narrative

At the on site visit the field service engineer (fse) checked the device and found it meets company specifications.The system history shows that the laser was verified successfully prior to and after the day of treatment.The patient data review shows that no clinical root cause can be identified.The review of the logfiles revealed the reported patient was the second case on that day.The treatment shows interruptions of the user by releasing the laser pedal.No further abnormalities or deviations can be detected.Also all other treatments on that day show no error or warning message and the user renewed the energy check in the recommended time range.All treatments on that day were interrupted several times by the user releasing the laser pedal but no other issue is detectable.No technical problem can be identified.No technical root cause was identified as the product was found to be within specifications.The root cause cannot be determined conclusively.(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
• Manufacturer (Section G): WAVELIGHT GMBH; am wolfsmantel 5; erlangen 91058 ; GM 91058
• Manufacturer Contact: rita lopez ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8175514846
• MDR Report Key: 6037946
• MDR Text Key: 57774314
• Report Number: 3003288808-2016-01820
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713
• Other Device ID Number: 00380659907135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR