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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 0070-1006
Event Date 05/15/2008
Event Type  Injury  
Manufacturer Narrative

 
Event Description

Surgeon reported that the patient at the one month post op examination, following a lasik treatment exhibited a 1. 1 diopter over correction in the right eye, and 0. 9 diopter over correction in the left eye.

 
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Brand NameVISX WAVESCAN WAVEFRONT SYSTEM
Type of DeviceWAVEFRONT MEASUREMENT
Manufacturer (Section D)
AMO MANUFACTURING USA, LLC.
510 cottonwood dr
milpitas CA 92705 493
Manufacturer (Section G)
AMO MANUFACTURING USA, LLC
510 cottonwood dr
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e. st. andrew place
santa ana , CA 92705-4933
7142478598
MDR Report Key1079755
Report Number3006695864-2008-00002
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Remedial Action Notification
Type of Report Initial
Report Date 06/19/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number0070-1006
Device Catalogue Number0070-1006
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Event Location Outpatient Treatment Facility
Date Manufacturer Received05/28/2008
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberPENDING

Patient TREATMENT DATA
Date Received: 07/18/2008 Patient Sequence Number: 1
Treatment
EXCIMER LASER
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