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

MAUDE Adverse Event Report: ADVANCE MEDICAL OPTICS, INC. VISX S4 IR LASER, OPTHALMOLOGY

  • 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
 

ADVANCE MEDICAL OPTICS, INC. VISX S4 IR LASER, OPTHALMOLOGY Back to Search Results
Model Number S4 IR
Event Date 07/08/2008
Event Type  Malfunction  
Event Description

During the treatment for lasik, the machine automatically shut off and would not restart. The procedure had to be aborted when only 50% complete. ====================== manufacturer response for excimer laser, visx s4 ir======================they are servicing the machine today, 7/9/08. They reported on the phone they had not seen such a problem.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVISX S4 IR
Type of DeviceLASER, OPTHALMOLOGY
Manufacturer (Section D)
ADVANCE MEDICAL OPTICS, INC.
1700 east saint andrew place
santa ana CA 92705
MDR Report Key1074470
Report Number1074470
Device Sequence Number1
Product CodeLZS
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/09/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/09/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Physician
Device MODEL NumberS4 IR
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/09/2008
Device Age11 yr

Patient TREATMENT DATA
Date Received: 07/09/2008 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
NO OTHER THERAPIES
-
-