Catalog Number 8065752200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Toxic Anterior Segment Syndrome (TASS) (4469)
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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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An ophthalmic surgeon reported that a patient experienced toxic anterior segment syndrome (tass) postoperatively.Patient and procedure outcome are unknown.
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Event Description
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Additional information was received, the facility does not feel the reported events are associated with the reported device.And informed, they were reporting for information purposes.
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Manufacturer Narrative
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This event does not meet criteria as a reportable malfunction, based on information received, following submission of the initial report.With current information received from the facility, it has been determined, that our device was not the contributory cause of the event.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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