Model Number CNA0T0 |
Device Problems
Material Discolored (1170); Particulates (1451)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that during an intraocular lens (iol) implant procedure, the lens was implanted into patient's eye and noticed polychromatic film appearing to be on the anterior side of the iol.Subsequently, it was removed during initial procedure and completed with new iol.Additional information was requested.There are two medical device reports associated with this complaint.This report is 1 of 2.
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Manufacturer Narrative
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The product was returned for analysis.Iol was received in one segment in a specimen container.Solution is dried on the iol.Approximately 50% of the optic is cut.One haptic is fractured at the gusset area and is partially attached.The optic is cracked/fractured - rejectable.The reported "sheen" is not observed.The origin of the reported complaint cannot be confirmed from the returned product.Complaints have been received describing that lenses were reported by doctors for the presence of a ¿polychromatic sheen¿ visible.No harm to patients reported.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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