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 10/14/2017

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.No abnormalities that could have contributed to this event were found.The associated device was released based on company acceptance criteria.The manufacturer internal reference number is: 2017-105599.

Event Description

A risk manager reported a patient with diffuse lamellar keratitis one day following lasik treatment.A flap lift and rinse was performed and topical steroid, antibiotic and a non steroidal anti-inflammatory was applied to the stromal bed.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

Review of the logfiles for the day of treatment shows during start up the vacuum check, the energy check and the ablation check were completed successfully without issue.Also the image of the ablation check shows a valid and good test.During the reported treatment no abnormalities can be identified and the treatment was finished with good suction values and no long suction time.According to user manual the user used energy settings which are within the defined recommended arrangement of pulse energy.The user performed energy checks in the required time range so all treatments were performed in this range to the last energy check.No technical problem with the system can be identified by reviewing the logfiles.Technical root cause could not be determined as the system is performing within specifications and as intended.(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: 7185603
• MDR Text Key: 97079555
• Report Number: 3003288808-2018-00091
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/18/2017,03/27/2018

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: 00380659909412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2017
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 12/18/2017
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2015
• 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): Required Intervention
• Patient Age: 31 YR