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 12/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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The device history records (dhr) for the device were reviewed.The associated device was released based on 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.No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date.The manufacturer internal reference number is: (b)(4).
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Event Description
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An optometrist reported a patient presented with blurry vision in both eyes one day post lasik.The patient was noted to have 3+ diffuse lamellar keratitis in the right eye.The topical steroid dosage was increased and an oral steroid was prescribed.Additional information received states a flap rinse was performed and the patient's symptoms resolved.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: 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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