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
Bacterial Infection (1735); Conjunctivitis (1784); Endophthalmitis (1835); Visual Impairment (2138); Fibrosis (3167); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/10/2023 |
Event Type
Injury
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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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Event Description
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A customer reported that after the cataract surgery, patient had endophthalmitis in right eye vision decrease, positive for p.Acne and patient used steroids and antibiotics as a medical intervention.Before surgery patient's bcva was 20/50 -2 and after surgery 20/cf 1 ft.Patient's condition was unknown.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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A nurse reported that after 14 days of cataract surgery, patient experienced endophthalmitis in right eye vision decrease, positive for p.Acne.It was treated with intravitreal tap procedure and antibiotics and steroid medications.Current patient condition was unknown.Before surgery patient's bcva was 20/50 -2 and after surgery 20/cf 1 ft.Patient had conjunctival inflammation was <2+, aqueous cell was 3+, aqueous fibrin was present, hypopyon was absent.Intravitreal tap and injection of vancomycin, ceftazadime and dexamethasone used as a intervention for the events.It was unknown whether the intervention for the events effective or not.No sutures used, no surgical complications.
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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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