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

Catalog Number 8065990713RP

Device Problems Improper Device Output (2953); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 10/01/2015

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.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.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported an energy fluctuation during lasik treatment.He reports post lasik treatment the patients left eye is over corrected.Additional information has been requested.

Manufacturer Narrative

No abnormalities that could have contributed to this event were found during the device history records review and the product was released according to company acceptance criteria.The reported event could not be confirmed.The manufacturer internal reference number is: (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: eddie darton, md, jd ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8175686660
• MDR Report Key: 5189607
• MDR Text Key: 29921871
• Report Number: 3003288808-2015-06709
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990713RP
• Device Lot Number: ASKU
• Other Device ID Number: 00380659907135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• 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