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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC VISX EXCIMER LASER

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AMO MANUFACTURING USA, LLC VISX EXCIMER LASER Back to Search Results
Model Number STAR S4 IR
Device Problem No Known Device Problem
Event Date 11/11/2010
Event Type  Injury  
Event Description

The clinic doctor reported that a laser vision correction pt presented at the post-op examination with a decentered ablation in each eye. The pt reported experiencing distorted vision in both eyes and at five weeks post-op had a best corrected visual acuity of 20/30 in the right eye and 20/25 in the left eye.

 
Manufacturer Narrative

An amo medical monitor reviewed the pt charts and indicated that he and the treating doctor were not able to determine the reason for the decentered ablations. The customer did not report this issue to amo when it occurred and did not request field service for the equipment or clinical support. A review of our service records reveals that the equipment was serviced about 6 weeks after the event for an unrelated issue. All pertinent info available to amo has been submitted. Should new info that changes the facts and/or conclusion of this report become available, a supplemental report will be submitted.

 
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Brand NameVISX EXCIMER LASER
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 Key2348880
Report Number3006695864-2011-00119
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/19/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/15/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTAR S4 IR
Device Catalogue Number0030-2450
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Event Location Outpatient Treatment Facility
Date Manufacturer Received10/19/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2001
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: 11/15/2011 Patient Sequence Number: 1
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