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U.S. Department of Health and Human Services

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

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AMO MANUFACTURING VISX WAVESCAN WAVEFRONT SYSTEM WAVEFRONT MEASUREMENT Back to Search Results
Model Number 0070-0150
Device Problems Computer software issue; Incorrect measurement
Event Date 05/28/2008
Event Type  Injury  
Event Description

Prior to the lasik procedure, a treatment table from the wavescan 3. 9 software was generated that resulted in spherical overcorrection with greater than two diopters of induced astigmatism. Pt's preoperative vision was 20/40 without correction, 20/20 with manifest refraction of -1. 25 sph. At last visit in 2008, pt's vision was 20/100 without correction and his refraction was -0. 75 + 2. 50 x 055 with which he saw 20/25. The fellow eye was treated the same day with the same device with an outcome of 20/15 uncorrected vision. The plan is for him to undergo retreatment within the next three months.

 
Manufacturer Narrative

Error in software contributed to the event.

 
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Brand NameVISX WAVESCAN WAVEFRONT SYSTEM
Type of DeviceWAVEFRONT MEASUREMENT
Manufacturer (Section D)
AMO MANUFACTURING
510 cottonwood dr
milpitas CA 92705 493
Manufacturer (Section G)
AMO MANUFACTURING
510 cottonwood dr
milpitas CA 92705 493
Manufacturer Contact
carol kail
1700 e st andrew pl
santa ana , CA 92705-4933
7142478598
MDR Report Key1064053
Report Number1221842-2008-00010
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Remedial Action Notification
Type of Report Initial
Report Date 05/28/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number0070-0150
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 Manufactured10/01/2001
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: 06/20/2008 Patient Sequence Number: 1
Treatment
EXCIMER LASER
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