Catalog Number 8065750469 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Conjunctivitis (1784); Eye Infections (4466); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/29/2022 |
Event Type
Injury
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Event Description
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A physician reported that a patient experienced toxic anterior segment syndrome, slight pain, tyndall, conjunctival inflammation, aqueous cells, conjunctival infection when an ophthalmic viscoelastic was used.Patient was given with steroids, antibiotics and non-steroidal anti-inflammatory medications.Symptoms were resolved.No further information expected as customer was unwilling to provide.Additional information received clarifying the reporter suspects phacoemulsification handpiece for the 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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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The handpiece was not returned for evaluation.A non-conformance-based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was 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.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The product under investigation is not a serviceable device.Therefore, a service record review was not performed.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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