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Model Number MXUT |
Device Problems
Break (1069); Material Split, Cut or Torn (4008)
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Patient Problems
Eye Injury (1845); Capsular Bag Tear (2639); No Code Available (3191)
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Event Date 10/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Evaluation of the returned device was performed.One opened lens box was returned missing the peel pouch, patient identification card, labels and directions for use (dfu).The lens was received in a dried condition and was in the vial.Particulates, saline dendrites and dried solutions were visible on the optic.Visual inspection found the lens was in three pieces.The optic was torn off and cut in half.Approximately half of one haptic was broken/torn off and was lying loose in the vial.The remaining piece of the optic was bent.The other haptic was torn off at the optic and was missing.Due to the condition of the returned lens, functional testing could not be performed.Based on the evaluation of the returned lens, the cause of the damage to the lens could not be determined.Investigation of this event is in progress.A supplement report will be submitted upon completion of the investigation.
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Event Description
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It was reported that the lens was loaded without complication.The surgeon injected the intraocular lens (iol) into the left eye, and then noticed that the front haptic was broken and tore the capsular bag.It was also reported that the back haptic was also broken.The iol damage was noticed intraoperatively, during contact with the patient.There was no loss of vitreous fluid and no vitrectomy was performed.The original incision was enlarged, but no sutures were required.A second iol of a different model was implanted successfully.The surgeon believes that the iol was received damaged, and both haptics being broken was very unusual.
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Manufacturer Narrative
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The product evaluation could not verify the failure mode for capsule damage.However, it did confirm the reported damaged haptics.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.There have been no other complaints for this lot to date.Based on the information provided, we are unable to determine a root cause.No additional investigation or corrective action is necessary at this time.
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Search Alerts/Recalls
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