Model Number SN6AT3 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Loss of Vision (2139)
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Event Date 02/11/2018 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported following the implant of an intraocular lens (iol), the lens appears opaque and matte.The patient is reported to have partially lost some of their vision and the vision that is still there is 'matte'.Additional information was requested.
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Manufacturer Narrative
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Additional information provided in b.5., b.6., b.7., and d.3.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional clarification was received from the surgeon reporting the patient is experiencing nanoglistenings on the implanted lens.
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Search Alerts/Recalls
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