Model Number SN6AT3 |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Dizziness (2194)
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Event Date 01/15/2018 |
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.The manufacturer internal reference number is: (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 was feeling like it wasn't right, toric was too strong (dizzy).The iol was exchanged for a different iol 1 month after initial implantation.Additional information has been requested.
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information was provided by the surgical coordinator, indicating that the patient experienced blurry vision and the outcome of the event has resolved with treatment.
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Manufacturer Narrative
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Evaluation summary: the product was returned for analysis and the reported complaint could not observed.Additional observations were as follows:
iol returned in a specimen container.Solution is dried on both surfaces of the optic and haptics.The optic is torn/split-cut and scratched/marked-rejectable.The optic has two perpendicular torn/split-cuts, resulting in approximately one quarter of the optic being removed and returned.Optical power & resolution could not be verified due to the extensive optic damage.We are unable to determine the root cause for the reported complaint.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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