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Model Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dry Eye(s) (1814); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
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Event Description
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A consumer reported that following an intraocular lens (iol) implant procedure, the patient needs glasses for reading and prescribed drops for dry eye.Also within a few months yag capsulotomy was done to the patient.No further information available.There are two medical device reports associated with this patient.This report is associated with the left eye.
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Search Alerts/Recalls
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