It was reported that following a cataract surgery where the procedure pack was used, the patient experienced an unspecified infection.Reportedly, the patient was referred to a retinal specialist where unspecified cultures were drawn and an unspecified antibiotic treatment was started.The patient has required follow-up care from the retinal specialist.No additional information was provided by the reporting facility and it is unknown what component(s) from the procedure pack were used at the time of the cataract surgery.No sample was returned to the pack manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported infection and the need for medical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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Lot number corrected in section d4 following receipt of additional information from the reporting facility.The pack manufacturer received samples for evaluation from the reporting facility.When the samples were examined, no holes, tears, or punctures that could comporomise sterility were noted on the breather pouch.When the samples were opened and examined for particulate, missing components, or other possible production assembly issues, none were noted.A root cause for the reported incident was unable to be determined.If additional relevant information becomes available, another supplemental mdr will be filed.
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