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

Catalog Number 8065990601

Device Problem Improper Device Output (2953)

Patient Problem No Code Available (3191)

Event Date 02/26/2016

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.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported multiple cases of under correction following lasik treatment.The surgeon believes the under correction was due to a low energy reading on the laser.There are two related reports for this patient.This report addresses the patient's right eye, and another manufacturer report will be filed for the fellow eye.

Manufacturer Narrative

(b)(4).

Event Description

Upon follow up, reported under correction is now showing an over correction.

Manufacturer Narrative

The system history shows that the laser was verified successfully prior to the day of treatment.The logfile review shows no abnormalities that could have contributed to the reported event.The suspect treatment was completed and all laser system functions were within specifications.No technical root cause was identified as the product was found to be within specifications.The root cause could not be identified conclusively.(b)(4).

• Brand Name: ALLEGRETTO WAVE EYE-Q 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: 5592083
• MDR Text Key: 43161300
• Report Number: 3003288808-2016-00698
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990601
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2009
• 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
• Patient Age: 47 YR