Model Number SN6AT3 |
Device Problem
Compatibility Problem (2960)
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Patient Problem
Visual Impairment (2138)
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Event Type
Injury
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Manufacturer Narrative
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A sample device was not returned for analysis.Complaint history and 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 nurse reported that following an intraocular lens (iol) implant procedure, a patient experienced problems seeing at distance with great difficulty.The iol was exchanged for another lens two months following the initial implant procedure.The reason given was "wrong iol power; refractive surprise." additional information has been requested.
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Manufacturer Narrative
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Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received indicating the initial iol was exchanged for another lens with two diopters difference in power.
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Search Alerts/Recalls
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