Catalog Number 8065990739 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Keratitis (1944); Blurred Vision (2137); Visual Disturbances (2140)
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Event Date 08/19/2019 |
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 september 24, 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.(b)(4).
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Event Description
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An optometrist reported patient with stage one to two diffuse lamellar keratitis of the left eye three days following lasik treatment.The patient reports a haze and being a little sensitive to light.The symptoms are greater in the left eye than the right eye.The topical steroids were increased.Additional information received confirming the patients symptoms have resolved postoperatively.There are two related reports for this patient.This report addresses the patient's left 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.Logfile review shows no abnormalities that could have contributed to reported event.All laser system functions were within specifications on this day.No technical root cause was identified as the product was found to be within specifications.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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