Catalog Number 8065990739 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
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Event Date 11/05/2020 |
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.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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A healthcare professional reported a patient experienced halos, glare, shadows and fuzzy vision following lasik procedure.The patient notes hazy vision in the left eye.Additional information has been requested.
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Manufacturer Narrative
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A review of the device history record traceable to the reported serial number indicates that the product was processed and released according to the product¿s acceptance criteria.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 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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