Catalog Number 8065990739 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Dry Eye(s) (1814); Pain (1994); Blurred Vision (2137); Discomfort (2330)
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Event Date 10/22/2018 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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An optometrist reported a patient that complained of pain/discomfort in the right eye upon awakening from sleep nine months post photo refractive keratectomy (prk).The patient also noted dry eye and blurry vision.Additional information has been requested.
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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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