Catalog Number 8065990739 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Keratitis (1944)
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Event Date 01/07/2019 |
Event Type
Injury
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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.No udi required as this device was out of production prior to the (b)(4) 2014 udi regulation date.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.The manufacturer internal reference number is: (b)(4).
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Event Description
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An optometrist reported a patient with diffuse lamellar keratitis of the right eye three days following lasik treatment.The patient reported being light sensitive.The topical steroids were increased.Additional information requested.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.
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Manufacturer Narrative
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A review of the technical service onsite history showed no abnormalities that could have contributed to this event.The laser was successfully verified prior to the day of treatment.The root cause could not be identified conclusively the manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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