Model Number CNW0T4 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device was not returned for analysis.The product history record could not be reviewed because facility did not provide a lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The complainant indicates the use of non company viscoelastic, which is not qualified for use with company lens model, this is not a qualified company product combination.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that following implantation of an intraocular lens (iol) the that a foreign material of about 3mm was found adhered to the rear surface of the iol after implanting.The foreign material was not there when it was set up.It may be deposits from the injector.The foreign material was removed by forceps and the surgery was completed without product replacement.Additional information was requested.
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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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Additional information was requested and received product information.
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Manufacturer Narrative
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The product was not returned for analysis.The received photo shows an implanted iol (intraocular lens)on a monitor screen, there appears to be a mark/fibre in the middle of the optic and also marks near the edge of the optic.The exact location of the marks cannot be confirmed.Based on our observation of the attached photo, there appears to be foreign material on the iol.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.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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