MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 8065990941

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Keratitis (1944)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.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.(b)(4).

Event Description

A doctor reported that three patients presented with symptoms of diffuse lamellar keratitis one day post lasik.No additional information available.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

At the onsite visit, the fse (field service engineer) replaced the laser head and verified the system according to specifications.Log file review shows that according to the user manual, the user used energy settings which are within the defined recommended arrangement of pulse energy.During the complete day the energy was stable with no abnormalities.No technical problem can be identified on the reported day.The local clinical application specialist (cas) visited the site and states that dlk is a known side effect/complication of the lasik procedure.Energy and separation settings used during the flap cut showed differences compared to common settings (different bed- side- and canal cuts require more time for re-alignment between the steps).The contribution of the setting used to dlk is possible but likely are affected at the periphery and corneal bed.The total energy delivered during the cut could cause dlk but is less likely in this case.The appearance of dlk is not with immediate effect and sporadic, directing to other contributing factors.No technical root cause was identified.The root cause cannot be determined conclusively.Potential contributing factors to the reported issue may be the settings used as different bed- side- and canal cuts require more time for re-alignment of energy between the steps.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 FEMTOSECOND LASER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• 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: nadia bailey ; am wolfsmantel 5; erlangen 91058 ; GM 91058 ; 8176152330
• MDR Report Key: 6670111
• MDR Text Key: 78483277
• Report Number: 3003288808-2017-01458
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Other Device ID Number: 00380659907142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 07/27/2017
• Supplement Dates FDA Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2013
• 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