No device sample returned for manufacturer analysis.A lot number was provided; lot history, device history, sterilization records and trend reporting were reviewed.No issues or nonconformance's were found and no trends were identified, no root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.
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The patient reports that they sought emergency medical treatment for redness and swelling of the eyes and was diagnosed with periorbital cellulitis, conjunctival chemosis, and episcleritis in both eyes (ou).The patient states this was confirmed via a ct scan and was prescribed cephalexin and tobradex.The patient was discharged and advised to follow-up with their eye care provider for follow-up, the patient was scheduled to be seen 8 april.Good faith efforts were made to obtain additional information from the patient on the incident and medical treatment received without success, further information is unknown.This event is being reported in an abundance of caution due lack of medical documentation and the potential severity of periorbital cellulitis.While it is unlikely the device was a cause or contributing factor, the relationship between the device and the event is unknown.
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