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.This involves both right and left eye.Please refer to linked manufacturer report 9614392-2022-00029 for second associated incident report.
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This incident was reported by the patient's location of purchase as relayed by the end user.It was reported that the patient experienced eye infection in both eyes (ou).The user experienced symptoms of swelling (puffy eyes) and eye discharge and sought medical treatment.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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