Model Number SN6AT3 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Code Available (3191)
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Event Date 04/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.(b)(4).
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Event Description
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A health professional reported that after an intraocular lens (iol) implant surgery, a patient is experiencing uncorrected astigmatism.In the right eye.Additional information was requested and received with the preoperative and postoperative measurements including the target refraction.
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Event Description
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Additional information received stating the iol was not explanted and at the last visit to the eye clinic on (b)(6) 2020, the condition was unchanged and without any complications.
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Manufacturer Narrative
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Additional information provided in b.5., and b.6.Corrected information provided in b.6.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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