ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM, ACCESSORY, OZIL TORSIONAL HANDPIECE; UNIT, PHACOFRAGMENTATION
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Catalog Number 8065750469 |
Device Problems
Material Discolored (1170); Particulates (1451); Pitted (1460)
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Patient Problems
Corneal Edema (1791); Vitreous Floaters (1866); Inflammation (1932); Uveitis (2122); Vitritis (2181); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/10/2021 |
Event Type
Injury
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Event Description
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A surgeon reported that an phacoemulsification handpiece had white ¿specs¿, discoloration in the lumens, and potential pitting during a cataract surgery.The patient experienced toxic anterior segment syndrome (tass) post-operatively.The patient presented post-operative day two with floaters, no pain or erythema.Upon examination of the patient, the surgeon noted aqueous cell (anterior chamber reaction), conjunctival inflammation, mild microcystic edema and vitreous cell.The patient was prescribed post-operative steroid eye drops and antibiotics.No cultures were performed.The patient's symptoms have been improving without any additional treatment.
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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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The phacoemulsification handpiece (hp) was received and manufacturing device history record (dhr) reviews were performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.Phacoemulsification hp nonconformities occurred remains inconclusive.Although the existence of foreign materials were able to be confirmed, the exact identity, origin and quantity of the particles and fibers remains unknown.It should be known that handpiece are inspected during manufacturing for metal particulates the root cause of the reported ¿tass (toxic anterior segment syndrome) , aqueous cells, medical intervention, and corneal edema¿ is inconclusive.The root cause of the reported ¿abnormalities in hp is also 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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