Model Number SN6AT3 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Blurred Vision (2137); Visual Impairment (2138)
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Event Date 12/19/2019 |
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.(b)(4).
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Event Description
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A facility representative reported that following an intraocular lens (iol) implant procedure, the patient experienced blurry vision at distance.The iol was replaced for another lens model with the same lens diopter approximately one month following the initial implant procedure.
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Manufacturer Narrative
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Product evaluation: the product was not returned for analysis.Additional information: the complainant states the use of a viscoelastic which is not qualified to be used with the associated iol/cartridge/handpiece combination.Root cause: the root cause for the reported complaint could not be determined.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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