Catalog Number 8065990601 |
Device Problem
Improper Device Output (2953)
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Patient Problem
No Information (3190)
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Event Date 03/11/2016 |
Event Type
Injury
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Manufacturer Narrative
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Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information has been requested.No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date.(b)(4).
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Event Description
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A surgeon reported multiple cases of under correction following lasik treatment.The surgeon believes the under correction was due to a low energy reading on the laser.There are two related reports for this patient.This report addresses the patient's right eye, and another manufacturer report will be filed for the fellow eye.Additional information has been requested.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Upon follow up, reported under correction still present.
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Manufacturer Narrative
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The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.The system history shows that the laser was verified successfully prior to the day of treatment.The root cause could not be identified conclusively.(b)(4).
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Search Alerts/Recalls
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