This incident was reported by the patient's location of purchase as relayed by the patient.It was alleged that the patient has been experiencing recurrent eye infections.Patient alleged that the eye care provider believes infection is due to contact lenses.Good faith efforts have been made to obtain further information without success.As of the date of this report, additional information is unknown.This event is being reported in an abundance of caution due to the allegation of recurrent eye infections with the lack of medical information, unconfirmed diagnosis, and unknown patient resolution.Should further information become available, the manufacturer will complete further investigations as appropriate and submit a follow-up report as applicable.
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(h3): no product has been made available for manufacturer analysis and no lot number provided for manufacturer investigation.Given the lack of available device information, the manufacturer is unable to complete further investigations at this time and no root cause can be established.The relationship between the coopervision device and the event is unconfirmed.Should further information become available, the manufacturer will complete further investigations as appropriate and submit a follow-up report as applicable.
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