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

MAUDE Adverse Event Report: AMO MANUFACTURING USA LLC. VISX STAR EXCIMER LASER

  • 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
 

AMO MANUFACTURING USA LLC. VISX STAR EXCIMER LASER Back to Search Results
Model Number STAR S4 IR LASER
Event Date 01/16/2009
Event Type  Injury  
Event Description

The surgeon reported a decentered ablation with a patient treated for laser vision correction in the left (os) eye. At post-op exam, patient exhibits loss of best corrected visual acuity due to a nasally decentered ablation. Patient may be retreated to correct vision loss.

 
Manufacturer Narrative

The laser system was examined and tested at the customer location by an amo service technician. No issues were detected that related to the incident however, it was noted that the y cal platform was misaligned.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVISX STAR EXCIMER LASER
Manufacturer (Section D)
AMO MANUFACTURING USA LLC.
510 cottonwood drive
milpitas CA 92705 493
Manufacturer (Section G)
AMO MANUFACTURING USA LLC.
510 cottonwood drive
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e. st. andrew place
santa ana , CA 92705-4933
7142478598
MDR Report Key1364701
Report Number3006695864-2009-00030
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Foreign,User facility
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 03/20/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/16/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSTAR S4 IR LASER
Device Catalogue Number0030-4966
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Manufacturer Received03/20/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/16/2009 Patient Sequence Number: 1
-
-