MAUDE Adverse Event Report: WAVELIGHT GMBH ALLEGRETTO WAVE 200HZ EXCIMER LASER; OPHTHALMIC EXCIMER LASER SYSTEM

Catalog Number 8065990723

Device Problems Use of Incorrect Control/Treatment Settings (1126); Failure to Deliver Energy (1211); Improper or Incorrect Procedure or Method (2017)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/22/2015

Event Type  Injury  

Event Description

A nurse reported cases of overcorrection following refractive surgery.This case is for a patient¿s left eye who experienced an under correction, at four months post lasik treatment.Company representative informed that the nomogram was incorrectly applied and the energy was adjusted too high at the fluence test, by the customer.Training was scheduled for surgeons involved.Additional information has been requested but not received to date.

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 manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Evaluation summary: no material was returned for evaluation.A clinical application specialist identified during the training of the personal on (b)(4) 2015 that the energy settings were correct, confirmed by the passed fluence tests.Log file review showed the treatment was completed to 100 %.All laser system functions were within specifications for the respective treatment.The system history showed that the laser was verified successfully prior and after the date of treatment.The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on manufacturer acceptance criteria.No technical root cause was identified as the product was found to be within specifications.The root cause cannot be determined conclusively.

• Brand Name: ALLEGRETTO WAVE 200HZ 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: 4928384
• MDR Text Key: 6430623
• Report Number: 3003288808-2015-05966
• Device Sequence Number: 1
• Product Code: LZS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P020050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 8065990723
• Device Lot Number: ASKU
• Other Device ID Number: V2-1.01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2006
• 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