Model Number CNA0T0 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
Visual Impairment (2138)
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Event Date 12/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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The product was not returned for analysis.The root cause is deemed to be manufacturing related.Incorrectly labelled product was released.Internal investigation was raised as part of this investigation.Based on the results from the product history record, the products met release criteria.There has been several additional complaints were reported.The manufacturer internal reference number is: (b)(4).
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Event Description
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A healthcare professional reported that following an intraocular lens (iol) implant procedure, the patient experienced refractive surprise.The lens was explanted in a secondary procedure for another iol for adjusting the biometric calculation to the diopter power.Additional information has been requested and received.
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Event Description
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Additional information was received and was further clarified that the refractive surprise was of +4,00.The replacement lens that was implanted still remains in the eye.
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Manufacturer Narrative
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In the initial mdr missed to report outcome of reportable malfunction, corrected information provided in b.2.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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