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 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

H.3., h.6.: 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 facility representative reported poor suction in the unknown patient eye during unknown timing of the surgery.There are multiple related reports for this facility.This report addresses a patient interface (pi)(b)(6) and additional manufacturer reports will be filed.

Manufacturer Narrative

A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A sample was not received at the production site and insufficient information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Sample received at suspect.The sample evaluation resulted in the following statement: visual inspection of the applanation cone with a photomicroscope shows debris, an eye print that indicates eye contact, and liquid on the applanation surface.It is unclear whether there were debris on the applanation surface before docking procedure or only after docking.The most possible root cause for debris is fall out of particles during transportation from customer to suspect was not originally closed.Functional inspection of the suspect product shows a beam control check error during focus control/calibration check.According to the manual frequently reported issues and answers suspect: this beam control check error appears during the focus control routine of the applanation cone.A possible reason is that the applanation cone is dirty or damaged.The user has to cancel the treatment and start again, using a new applanation cone.In this case the beam control check error occurs due to the surgery residues on the applanation surface, which indicates eye contact.A root cause for the customers reported event could not be determined because the returned product met manufacturer¿s specifications; it is not likely that a product malfunction could have contributed to the reported event.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 ; 8007579780
• MDR Report Key: 17442435
• MDR Text Key: 320231694
• Report Number: 3003288808-2023-00194
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00000000000000
• UDI-Public: 00000000000000
• 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,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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: 14YCWE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1