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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 0070-1006R
Device Problems Computer software issue; Incorrect measurement
Event Date 09/08/2008
Event Type  Injury  
Manufacturer Narrative

The wavescan equipment was tested and examined at the customer location by an amo service technician. The system met all amo specifications. The physician did not use the cluster mode to choose the pt's treatment as instructed in the mfr's urgent device correction letter of 07/25/08. The wavescan software was revised on two months later.

 
Event Description

Cv treatment induced an unexpected +4 cylinder on a male pt.

 
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Brand NameVISX WAVESCAN WAVEFRONT SYSTEM
Type of DeviceWAVEFRONT MEASUREMENT
Manufacturer (Section D)
AMO MANUFACTURING USA LLC
milpitas CA 92075 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 Key1194159
Report Number3006695864-2008-00023
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date 09/09/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number0070-1006R
Device Catalogue Number0070-1006R
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location AMBULATORY SURGICAL Facility
Date Manufacturer Received09/09/2008
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-3210-2008

Patient TREATMENT DATA
Date Received: 10/08/2008 Patient Sequence Number: 1
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