Model Number ACTR11 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The product was returned for analysis.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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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 is unknown, the product was not returned.Due to our internal 100% visual inspection and functional testing, we exclude that a broken ring has been sealed into the sterile packaging and sent to the vendor.Due to the information that the capsular tension ring could be loaded correctly, we suspect an improper handling.The reason of complaint is not detectable.The root cause is not detectable.To ensure an adequate investigation, we recommend the return of claimed product and the investigation regarding the injector/instruments (e.G.Manufacturer, type) which was used.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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One opened product packaging of company product from different lot was retuned.The complaint product and primary packaging are missing.We suspect that user related factors such as handling or loading techniques have contributed to the event.The root cause may be linked to the user.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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