Catalog Number 8065990739 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Foreign Body Sensation in Eye (1869)
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Event Date 11/19/2018 |
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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A center director reported a patient with pain, light sensitivity and foreign body sensation eleven days following photorefractive keratectomy.Additional information received; the site indicates this is expected following prk.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Further information received; the patients symptoms have resolved.
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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 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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