Catalog Number 8065990739 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Keratitis (1944); Blurred Vision (2137)
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Event Date 01/02/2019 |
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.The device history records (dhr) for the device was reviewed.The associated device was released based on company acceptance criteria.No udi required due to this device being out of production prior to the september 24, 2014 udi regulation date.(b)(4).
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Event Description
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An optometrist reported a patient with 1+ diffuse lamellar keratitis in the right eye two days post lasik.The patient noted blurry vision.Topical steroid dosage was increased.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: laser was successfully verified prior to and after treatment date.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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