The device is not available for evaluation.The device history records were reviewed and found test procedure document no.P-118-007 rev.Q, met specifications.The lot history, trend analysis, risk analysis, and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further information is available for this event.No corrective action required.The investigation is complete.
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The user facility in (b)(6) reported the patient received left eye phacoemulsification and intraocular lens implantation under local anesthesia.The surgery was completed with no issues.During the surgery, the patient was implanted with med + 21 spherical lens.The patient returned to the ward after the operation.There was no special reaction on the first postoperative day, and the patient was discharged for follow-up.On april 16, the patient was found to have membranous exudation on the surface of the intraocular lens in the left eye during outpatient follow-up and was given anti-inflammatory treatment for corneal edema and iridocyclitis.This event was reported to (b)(6) national medical device adverse events reporting system by (b)(6) hospital.
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