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 an ophthalmic operating handpiece used and after the surgery the patient experienced events toxic anterior segment syndrome.The patient current outcome was unknown.
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Event Description
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Additional information received that postoperatively patient experienced the events fibrin reaction anterior chamber and toxic anterior segment syndrome intense for which the patient was threated with drop therapy.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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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.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.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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