Model Number CCA0T0 |
Device Problem
Particulates (1451)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for analysis; the lens remains implanted.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
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Event Description
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A non healthcare professional reported that the physician noticed what he calls a polychromatic sheen on some of the lenses.The physician also added that he was seeing that mostly with specific models of the company's lenses.Additionally, the physician stated that he had noticed this with lenses in the past at another location as well.Additional information was received stating that the physician noticed it intraoperatively and left the lens implanted.As of now, none of the patients have any issues with visual acuity.
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Manufacturer Narrative
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The product was not returned for analysis.Photo was returned.Returned photo shows, what appears to be implanted iol.There are reflections of theatre lights on iol optic.The origin of the reported complaint cannot be confirmed from the returned photo.Based on our observation of the attached photo, there are reflections of theatre lights on implanted iol optic.The origin of the reported complaint cannot be confirmed from the returned photo.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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Additional information provided in h.3., h.6.And h.10.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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