• 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 WAVESCAN WAVEFRONT SYSTEM WAVEFRONT MEASUREMENT

  • 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 WAVESCAN WAVEFRONT SYSTEM WAVEFRONT MEASUREMENT Back to Search Results
Model Number 0070-0150
Event Date 05/06/2008
Event Type  Injury  
Event Description

Post operative data of a pt treated with the wavescan revealed an over correction of +1. 00 diopter in the right eye at one month following treatment. Pt's best corrected visual acuity is 20/20.

 
Manufacturer Narrative

The wavescan equipment was tested and examined at the customer location by an amo service tech. The system was found to be operating within the specification for the device.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVISX WAVESCAN WAVEFRONT SYSTEM
Type of DeviceWAVEFRONT MEASUREMENT
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 95035 000
Manufacturer Contact
carol kail
1700 e. st. andrew place
santa ana , CA 92705-4933
7142478598
MDR Report Key1081289
Report Number3006695864-2008-00004
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 06/23/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number0070-0150
Device Catalogue Number0070-0150
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 Received06/23/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2003
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: 07/22/2008 Patient Sequence Number: 1
-
-