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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS STAR S4 IR EXCIMER LASER

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ABBOTT MEDICAL OPTICS STAR S4 IR EXCIMER LASER Back to Search Results
Model Number STAR S4 IR
Event Date 07/31/2012
Event Type  Injury  
Manufacturer Narrative

(b)(4) - epithelial ingrowth. The clinic is reporting this event only and did not request field service or clinical support. Product inspection not performed. All pertinent information available to amo has been submitted.

 
Event Description

The clinic reported that a laser vision correction patient was treated for a lift flap enhancement in the left eye and returned at one week post op reporting a vision change and double vision in the left eye. The patient's visual acuity was 20/25 in the left eye. A slit lamp evaluation diagnosed an epithelial in-growth from 4-6 o'clock position. The patient was brought into the laser suite and the flap was lifted and the epithelial in-growth was removed. The patient was examined the next day and the patient's visual acuity was 20/20 in the left eye. The patient was fitted with a bandage contact lens which was removed after three days.

 
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Brand NameSTAR S4 IR EXCIMER LASER
Type of DeviceEXCIMER LASER
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA
Manufacturer (Section G)
ABBOTT MEDICAL OPTICS INC.
amo manufacturer
510 cottonwood drive
milpitas CA 95035
Manufacturer Contact
carol kail
1700 east st. andrew place
santa ana , CA 92705
7142478598
MDR Report Key2727666
Report Number3006695864-2012-00147
Device Sequence Number1
Product CodeLZS
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/15/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/05/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Physician
Device MODEL NumberSTAR S4 IR
Device Catalogue Number0030-1479
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/15/2012
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/14/1996
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: 09/05/2012 Patient Sequence Number: 1
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