Catalog Number 8065750469 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fibrosis (3167); Toxic Anterior Segment Syndrome (TASS) (4469)
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Event Date 08/01/2023 |
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 physician reported that during the surgery an ophthalmic operating handpiece used and patient experienced the event toxic anterior segment syndrome.There was no current outcome reported for the event.No other complication occurred.
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Event Description
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Additional information received that postoperatively patient experienced fibrin reaction in anterior chamber which the patient was treated with eye drops.The symptoms are resolved.
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Manufacturer Narrative
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Additional information provided in sections b.2, b.5 and h.6.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The product under investigation is not a serviceable device.Therefore, a service record review was not performed.Based on the information obtained, the root cause of the reported event is inconclusive.Specific product identifiers (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 /serial number cannot be performed as the serial number is unknown.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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