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 cooper vision 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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This incident was reported by the patient, to their location of purchase, who provided the information to the manufacturer.Limited information has been made available.It was alleged that the patient experienced two infections in her left eye (os) due to contact lens.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 lack of medical information, unconfirmed diagnosis, and unknown patient resolution.Should further information become available, a follow-up report will be submitted as appropriate.
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