MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 EASYPACK PATIENT INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number 1515

Device Problem Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2021

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported loss of suction with a patient interface (pi) on a patient¿s right eye during a lasik procedure.The physician switched the procedure to photo refractive keratectomy (prk).Additional information has been requested.There are multiple related reports for this facility.This report addresses pi 3000344220 and other manufacturer reports will be filed.

Manufacturer Narrative

No lot number was identified with this complaint, therefore the manufacturing documentation was not reviewed.All product and batch history records are quality reviewed prior to product release.The root cause cannot be identified conclusively because no further information, logfiles or sample have been received.The manufacturer internal reference number is: (b)(4).

• Brand Name: WAVELIGHT FS200 EASYPACK PATIENT INTERFACE
• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 12391617
• MDR Text Key: 268919974
• Report Number: 3003288808-2021-00384
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1515
• Device Catalogue Number: 8065998299
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: WAVELIGHT FS200 FEMTOSECOND LASER; WAVELIGHT FS200 FEMTOSECOND LASER
• Patient Age: 27 YR
• Patient Sex: Male