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 corrective action required.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 topical anesthesia and was implanted with a + 24.5 degree med spherical intraocular lens during the operation.The surgery was completed with no issues, and the patient returned home after the operation.On the first postoperative day, visual acuity was 0.8 and there was no special reaction in the anterior part of the eye.One week after surgery, membranous exudation on the surface of the intraocular lens was found, the pupil had adhesion, the intraocular pressure was normal, and the visual acuity was 0.3.The patient received tobradex, mydriasis eye drops, and para-bulbar injection of dexamethasone with an impression of iridocyclitis treatment for corneal edema, iridocyclitis, ocular hypertension.This event was reported to china national medical device adverse events reporting system by shanghai post and telecommunication hospital.
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