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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING USA LLC VISX WAVESCAN WAVEFRONT SYSTEM WAVEFRONT MEASUREMENT

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AMO MANUFACTURING USA LLC VISX WAVESCAN WAVEFRONT SYSTEM WAVEFRONT MEASUREMENT Back to Search Results
Model Number 0070-0150
Event Date 05/16/2008
Event Type  Injury  
Event Description

Prior to the lasik procedure, a treatment table from the wavescan 3. 9 software was generated that resulted in an induced astigmatism of 3. 2 diopter in the right eye and 1. 2 diopter in the left eye. In addition, the right eye received an over correction of 2 diopters. Pt's uncorrected visual acuity is 20/40 in the right eye and 20/30 in the left eye.

 
Manufacturer Narrative

Examination of the pt treatment did not reveal any miscalculations.

 
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Brand NameVISX WAVESCAN WAVEFRONT SYSTEM
Type of DeviceWAVEFRONT MEASUREMENT
Manufacturer (Section D)
AMO MANUFACTURING USA LLC
510 cottonwood drive
milpitas CA 95035 493
Manufacturer (Section G)
AMO MANUFACTURING USA LLC
510 cottonwood drive
milpitas CA 95035 493
Manufacturer Contact
carol kail
1700 e st. andrew place
santa ana , CA 92705-4933
7142478598
MDR Report Key1120483
Report Number3006695864-2008-00010
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/16/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2008
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? Yes
Was the Report Sent to FDA? No
Event Location Outpatient Treatment Facility
Date Manufacturer Received07/16/2008
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2002
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: 08/14/2008 Patient Sequence Number: 1
Treatment
EXCIMER LASER
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