Model Number SN6AT4 |
Device Problems
Malposition of Device (2616); Appropriate Term/Code Not Available (3191)
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Patient Problem
Blurred Vision (2137)
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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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A nurse reported that an intraocular lens (iol) was explanted 3 month after implantation due to blurred vision, toric rotatory and power change.Additional information was requested, but no further information is available.
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Manufacturer Narrative
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Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was requested and received stating the lens was replaced with same model toric lens with different diopter.
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Search Alerts/Recalls
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