ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION SILVER SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065750469 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Corneal Edema (1791); Blurred Vision (2137); Eye Burn (2523); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/13/2024 |
Event Type
Injury
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Event Description
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A customer reported that during a cataract surgery utilizing an ophthalmic system, phacoemulsification handpiece and phacoemulsification tip the female patients experienced corneal burn, severe decrease in visual acuity (va), and corneal edema with endothelial folds in right eye.The patients had preexisting conditions including optimal endothelial count and medium to low hardness of cataracts.The surgeon suspects that the corneal edema may be related to excessive parameters (90% torsional phaco) and the use of an incorrect balanced needle for medium-low hardness cataracts, potentially resulting in collapses.Additional treatment, including corticosteroids and anti-edema eye drops, was administered.All patients are currently in the post-operative recovery period.This complaint is pertaining the third of four reports received from the initial reporter and this report pertains to ophthalmic operating system involved for this reported event.
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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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Search Alerts/Recalls
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