ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number ASKU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Conjunctivitis (1784); Endophthalmitis (1835); Vitreous Floaters (1866); Hypopyon (1913); Red Eye(s) (2038); Blurred Vision (2137); Fibrosis (3167); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/08/2023 |
Event Type
Injury
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Event Description
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A nurse reported that after postoperative day 14 of cataract surgery with ophthalmic handpiece, intraocular lens, phaco tip, viscoelastic device, consumable , a 68 years old female patient experienced with endophthalmitis in left eye with symptoms of eye pain, blurry vision, floater, conjunctival inflammation was <1+, aqueous cell was 3+, aqueous fibrin was present with hypopyon.Patient was treated with intravitreal tap and antibiotics, corticosteroids medications.Culture results revealed no bacterial growth.Current patient condition was unknown.This is the report of patient 3 of 4.
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Specific product identifiers (lot number, batch number, and/or serial number) were not provided and could not be determined at this time.However, all device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.A review for complaints reported against this lot/batch/serial number cannot be performed as the lot/batch/serial number is unknown.The lot/batch/serial is unknown; therefore, a service history review cannot be performed.Based on the information obtained, the root cause of the reported event is inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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