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

Catalog Number 8065990941

Device Problems Patient-Device Incompatibility (2682); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2018

Event Type  malfunction  

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.Manufacturing record reviewed.No abnormalities that could have contributed to this event were found.(b)(4).

Event Description

A doctor reported a patient with an uncut side cut in the ten o'clock position which seems to be due to improper positioning of the flap which was almost overlapping near the limbus.Additional information has been requested.

Manufacturer Narrative

A review of the technical service onsite history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to and after the day of the treatment.Review of the logfiles for the day of treatment showed no errors or relevant warnings that could contribute to the reported event.During start-up of the system the vacuum, the energy and the ablation tests were performed without any issue.The logfile shows all treatments on that day were finished successfully.The reported treatment could be identified in the logfile.The user operated the surgery with recommend energy setting.No relevant deviation between planed and performed energy is detectable for the treatment.No technical root cause is detectable during logfile review.Clinical review stated that the treatment report showed extreme decentration of the flaps.The appearance of the bed and side cut does not show any abnormalities and the laser settings are well within the specifications.No conclusion for the reported sticky flap edge (side cut) can be found other than the decentrations.The surgeon used the standard settings as recommended.No technical root cause was identified as the system was operating within specifications.The most likely root cause for the incomplete flap and bubbles could be the combination of insufficient canal venting or extreme decentrations of the flap that was caused by docking technique of the user.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
• MDR Report Key: 7938750
• MDR Text Key: 123205181
• Report Number: 3003288808-2018-01630
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K101006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065990941
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR