Catalog Number 8065990739 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Foreign Body Sensation in Eye (1869); Keratitis (1944)
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Event Date 12/29/2018 |
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 two plus diffuse lamellar keratitis of the right eye one day following lasik treatment.The patient reported a foreign body sensation.The topical steroids were increased and a flap lift and rinse was performed.Additional information received; the symptoms resolved six days following onset.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 on site 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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