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

Catalog Number 8065990941

Device Problem Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

The device history records (dhr) for the device was reviewed.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 health professional reported, there was no vacuum when the laser fired during lasik flap creation.The surgery was completed with a new patient interface without patient harm.Additional information received confirming the left eye was the eye involved.

Manufacturer Narrative

A review of the technical service onsite showed no abnormalities that could have contributed to this event.The laser was successfully verified prior to and after the day of the treatment.Patient interface was returned.Failure analysis shows the reported problem cannot be confirmed.Visual inspection of the applanation cone of the patient interface shows no liquid remains on the applanation surface and no cut track.Functional testing of the patient interface with the laser system shows that the docking on a rubber test eye was performed without issue and a treatment would be possible.The docking process was retried several times and with two orientation of the suction ring but no lack of suction or instable suction could be reproduced.The root cause could not be determined conclusively.The reported problem cannot be confirmed.No problem with the returned patient interface or the laser system can be identified.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: 8782474
• MDR Text Key: 150968465
• Report Number: 3003288808-2019-00742
• 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
• Type of Report: Initial,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1