No product was returned to the manufacturer for device evaluation.A lot number was received, 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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It is reported that the patient experienced symptoms of a burning sensation, irritation and periorbital pain of the right (od) eye on (b)(6) 2020 and sought medical treatment.The patient presented with severe epithelial staining, moderate epithelial edema, limbal and bulbar injection, and trace stromal edema.Fluorescein staining identified central spk and a central epithelial defect.The patient was prescribed polytrim, prednisolone 1%, and motrin initially.The following day an amniotic membrane was placed on the right eye.Over the course of treatment and doxycycline and muro 128 were also prescribed.As of (b)(6), all medications and treatments were concluded and the incident fully resolved, however, the treating physician indicates that medical intervention and/or medications were required to prevent or preclude permanent impairment of eye function or structure from the condition of a persistent epithelial defect.
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