Model Number ACTR11 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2023 |
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 facility representative reported with a description of manufacture defective intraocular lens (iol).Additional information has been requested, received and stated scrub tech loaded capsular tension ring (ctr) correctly.When the surgeon inserted the ctr one of the loops was missing/cut off.It was replaced with new ctr during initial procedure.There was no harm to the patient.
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Manufacturer Narrative
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Correction information was provided in d.4.And h.4.On initial mdr the lot number was inadvertently not added.It is added in this report.The review of the device history record (dhr) of lot showed no irregularities or deviations.All released rings met their dimensions according to the review of the measurement protocols.A product examination could not be made due to the product was not returned.Hygienic condition of the product: unknown, the product was not returned.Due to our internal 100% visual inspection we exclude that a broken ring has been sealed into the sterile packaging and sent to the vendor.The reason of complaint is not detectable.We suspect that user related factors such a handing or loading techniques have contributed to the event.The root cause may linked to the user.To ensure an adequate investigation, we recommend the return of claimed product and the investigation regarding the injector/instruments (eg.Manufacturer, type) which was used.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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