Model Number SN6AT9 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Reaction (2414)
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Event Date 05/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The product investigation could not identify a root cause.The manufacturer internal reference number is: (b)(4).
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Event Description
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An ophthalmologist reported two cases of toxic anterior segment syndrome (tass) and slow release tass following intraocular lens (iol) implant procedures.Both patients had delayed but significant inflammatory reactions.It was managed with anti-inflammatory medication (intravitreal steroid one, topical the other).Additional information has been requested.There are two medical device reports associated with the two cases reported.This report is for one of two patients.
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Manufacturer Narrative
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Corrected information provided.Additional information was provided.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was provided indicating that the patient had developed 2+ aqueous cell.In the surgeon's opinion at the time, thought just excess inflammation; but a pattern of high toricity torics with inflammation developed.This was delayed excess inflammation diagnosed as toxic anterior segment syndrome.Topical medication adjustment was required.The intervention was effective and the event has resolved.
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Search Alerts/Recalls
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