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 05/20/2017

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.The device history records (dhr) for the device were reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on company 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 certified ophthalmic assistant reported a patient with mild diffuse lamellar keratitis (dlk) one day following lasik treatment of the right eye.The patient is using an antibiotic and a steroid ophthalmic drop.The symptoms were still continuing three days following treatment; patient is pending future follow up.Additional information has been requested.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

Additional information provided in describe event or problem.(b)(4).

Event Description

Additional information received, the symptoms resolved six days following onset.

Manufacturer Narrative

A review of the technical service onsite history showed no abnormalities that could have contributed to this event.The laser was successfully verified prior to and after the day of the treatment.Logfile review for the date of treatment shows no abnormalities that could have contributed to reported event.The treatments were completed to 100% and all laser system functions were within specifications during treatments on this day.No technical root cause was identified as the product was found to be within specifications.The root cause could be determined conclusively.(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: 6638331
• MDR Text Key: 77475327
• Report Number: 3003288808-2017-01353
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2017

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: 00380659909412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/13/2017
• Supplement Dates Manufacturer Received: 06/19/2017; 09/12/2017
• Supplement Dates FDA Received: 07/05/2017; 09/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2014
• 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
• Patient Age: 24 YR