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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
Event Date 09/01/2011
Event Type  Injury  
Manufacturer Narrative

Service was not requested for this event. An amo field service engineer performed a courtesy check on the equipment and no issues were found. The customer indicated that the equipment is operating well. A preventative maintenance was completed approx a week prior to the event and optics were replaced at this time. 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.

 
Event Description

The clinic reported that a laser vision correction pt presented with severe dry eye at the post op exam. The pt indicated having blurry vision and burning. The pt was implanted with lacrimal punctate plugs but complained of epiphora and irrigation from the plugs. The upper plugs were removed. The pt expressed dissatisfaction with the results and is upset with the delayed recovery. Artificial tears were prescribed for the dry eye and the pt is continuing to be monitored. The pt's uncorrected visual acuity is 20/25-1 in the right eye and 20/50 in the left eye. Best corrected visual acuity is 20/20 in the right eye and 20/25 in the left eye.

 
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Brand NameVISX EXCIMER LASER
Manufacturer (Section D)
AMO MANUFACTURING USA LLC
510 cottonwood drive
milpitas CA 92705 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 Key2312470
Report Number3006695864-2011-00115
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Physician
Type of Report Initial
Report Date 09/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/25/2011
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberSTAR S4 IR
Device Catalogue Number0030-1479
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Date Manufacturer Received09/27/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/1998
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: 10/25/2011 Patient Sequence Number: 1
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