Device Problem
Microbial Contamination of Device (2303)
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Patient Problems
Red Eye(s) (2038); Swelling (2091); Fungal Infection (2419)
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Event Type
Injury
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Manufacturer Narrative
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Analysis cannot be performed.No device returned for evaluation and lot number is unknown.The association between coopervision lenses and the event is unconfirmed.
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Event Description
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The patient was by his contact lens specialist in (b)(6) 2017 with no known findings.Shortly after, date unknown, the patients eye became red and swollen and the patient sought medical treatment.The patient was seen by an ophthalmologist and it appeared there was a fungal infection present in the patient's contact lens cleaning solution which has resulting in a fungal infection of the patient's eye.Good faith efforts have been made to obtain additional information without success, efforts are ongoing, additional information is unknown.This event is being reported in an abundance of caution due to incomplete diagnosis, lack of medical information, and unknown resolution.
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Manufacturer Narrative
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New information received 02 april 2018 with clarification of medical device/product involved in the incident.This product is not sold, distributed, or marketed or approved for sale or distribution in the united states, therefore this event does not meet the minimum criteria of an adverse reportable event in the us.
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Event Description
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New information received 02 april 2018 with clarification of medical device/product involved in the incident.This product is not sold, distributed, or marketed or approved for sale or distribution in the united states, therefore this event does not meet the minimum criteria of an adverse reportable event in the us.
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Search Alerts/Recalls
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