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.Two photos received, photo shows an iol in the lens case base well, half of the iol is missing.Photos 2 shows an iol resting on the flat part of the lens case base outside of the well, half of the iol is missing.The manufacturer internal reference number is: (b)(4).
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Half iol returned in iol case.Solution is dried on the iol.The remaining haptic is intact.The optic has surface fibers and is scratched/marked-rejectable.The sample was sent to particulate laboratory for testing.Comparison of the fibers¿ generated ir spectra to a library of spectra finds the best match to be wypall fibers (natural fibers).Two photos received, photo shows an iol in the lens case base well, half of the iol is missing.Photo 2 shows an iol resting on the flat part of the lens case base outside of the well, half of the iol is missing.The root cause for the reported complaint could not be determined.Based on the spectral comparison results, the returned fiber is wypall fiber (natural fiber).This is a commonly used material, including in medical products/environments.The product was subject to handling and the reported "foreign material" was highlighted post implantation.The origin of the observed foreign material could not be determined.No wypall paper is used in eca production areas.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed fiber would not meet our current release criteria.Based on the results from the product history record, the products met release criteria.No further action is warranted at this time.Alcon will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
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