• 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 8065990714
Device Problem Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/27/2019
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 during a lasik procedure.Additional information has been requested.
 
Manufacturer Narrative
The device history records (dhr) for the product lot was reviewed.No abnormalities that could have contributed to this event were found.The associated lot was released based on company's acceptance criteria.The root cause cannot be identified conclusively.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 Key9297988
MDR Text Key191318674
Report Number3003288808-2019-01115
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
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
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 Number8065990714
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/14/2019
Initial Date FDA Received11/08/2019
Supplement Dates Manufacturer Received01/13/2020
Supplement Dates FDA Received01/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-