Catalog Number 8065990739 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Foreign Body Sensation in Eye (1869); Hypersensitivity/Allergic reaction (1907); Pain (1994); Red Eye(s) (2038)
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Event Date 12/14/2018 |
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 pain, foreign body sensation, photophobia, and redness in the left eye one day post lasik.The patient was noted to have diffuse lamellar keratitis along the flap edge.The topical steroid dosage was increased.Additional information requested.
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Manufacturer Narrative
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A review of the technical service on site history showed no abnormalities that could have contributed to this event: laser was successfully verified prior to and after 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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