Model Number SN60WF |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: 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 surgeon reported that during a cataract surgery with an intraocular lens (iol) implantation, "foreign material was found to be adhered to the back side of iol after implanting." the foreign material was able to be removed and the iol remains implanted with no reported harm to the patient.Additional information has been requested.
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Manufacturer Narrative
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Evaluation summary: the cartridge was not returned for evaluation.Only a vial was returned with the reported foreign material.The opaque particle was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir).Comparison of the opaque particle's generated spectra to a library of spectra found the best match to be polypropylene; atactic.The indicated handpiece and viscoelastic combination are not qualified for use.A qualified lens model/diopter was indicated.The root cause for the reported foreign material could not be determined.No determination can be made without physical evaluation of the complaint sample.It cannot be ruled out that the cartridge may have been damaged.Polypropylene is a commonly used material in many medical products.The origin of the material could not be determined.The root cause for the reported issue could not be determined.
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Search Alerts/Recalls
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