Catalog Number 8065990739 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Pain (1994); Increased Sensitivity (2065)
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Event Date 12/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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No udi required as this device was out of production prior to the september 24, 2014 udi regulation date.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.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.(b)(4).
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Event Description
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An optometrist reported a patient with diffuse lamellar keratitis left greater than right eye one day following lasik treatment.The patient reported pain, photophobia and being unable to work.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 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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