• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED MEDICAL OPTICS VISX EXCIMER LASER WAVESCAN SOFTWARE 3.9/3.901 LASER, OPTHALMIC

  • 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
 

ADVANCED MEDICAL OPTICS VISX EXCIMER LASER WAVESCAN SOFTWARE 3.9/3.901 LASER, OPTHALMIC Back to Search Results
Event Date 05/06/2008
Event Type  No Answer Provided  
Event Description

Six patients undergoing lasik received an over-correction due to machine software generating inappropriate treatment tables. The manufacturer has sent us an urgent device correction notice, and has provided us with upgraded software (version 3. 92).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVISX EXCIMER LASER WAVESCAN SOFTWARE 3.9/3.901
Type of DeviceLASER, OPTHALMIC
Manufacturer (Section D)
ADVANCED MEDICAL OPTICS
1700 e st andrew place
santa ana CA 92795 493
MDR Report Key1074403
Report Number1074403
Device Sequence Number1
Product CodeLZS
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/02/2008
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Physician
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/02/2008
Event Location AMBULATORY SURGICAL Facility

-
-