BAUSCH + LOMB MILLENNIUM MICROSURGICAL SYSTEM; INSTRUMENT, VITREOUS ASPIRTION & CUTTING, AC POWER
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Model Number CX6000 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Corneal Edema (1791); Purulent Discharge (1812); Inflammation (1932)
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Event Date 04/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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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 + 31 spherical lens.The patient returned to the ward after the surgery.On the first day after surgery, there was an exudation reaction in the anterior chamber, and on the third day after surgery, the intraocular pressure increased.The patient received anti-inflammatory and ocular hypotensive treatment for corneal edema, iridocyclitis, and ocular hypertension.This event was reported to (b)(6) national medical device adverse events reporting system by (b)(6) post and telecommunication hospital.
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