Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WAVELIGHT GMBH WAVELIGHT FS200 FEMTOSECOND LASER; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Catalog Number 8065990941
Device Problems Suction Problem (2170); Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2020
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.(b)(4).
 
Event Description
A surgeon reported suction was lost during the bed cut of a flap creation.The cut was incomplete.The patient will be retreated in two months.There are two related reports for this patient.This report addresses the patient's left eye, and another manufacturer report will be filed for the fellow eye.
 
Event Description
Additional information was received that clarified there was not an incomplete flap creation.Vertical gas breakthrough (vgb) occurred and the doctor was unable to lift the flap.
 
Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a malfunction.The manufacturer internal reference number is: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10374743
MDR Text Key202975750
Report Number3003288808-2020-00466
Device Sequence Number1
Product Code GEX
Combination Product (y/n)N
PMA/PMN Number
K101006
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065990941
Was Device Available for Evaluation? No
Date Manufacturer Received08/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-