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Model Number MX60TP |
Device Problems
Material Twisted/Bent (2981); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)
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Event Date 10/08/2019 |
Event Type
Injury
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Manufacturer Narrative
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The product has been returned and is pending evaluation.The investigation is ongoing.
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Event Description
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It was reported that during the insertion of an intraocular lens (iol) there was a lens folding issue with the leading haptic.The incision was enlarged to remove the lens intraoperatively, and sutures were required.Though requested, no additional information has been received.
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Manufacturer Narrative
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The product evaluation has been completed.One opened lens box was returned complete with all components.The lens was in a dried condition inside the vial.Particulates, saline dentrites and dried solutions were visible on the optic.Visual inspection found one haptic bent.The delivery device was not returned.The cause of the damage cannot be determined.Functional testing cannot be performed using a delivery device due to the damaged.However, after re-hydrating the lens, the lens folded easily using folding forceps.The product evaluation could not verify the failure mode.No similar complaints have been received for this product lot.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the information provided, we are unable to determine a root cause.No corrective action is necessary at this time.
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Event Description
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The capsular bag was damaged in the right eye, and there was a loss of vitreous.A vitrectomy was performed and the incision was enlarged to remove the intraocular lens (iol).Sutures were used.The iol damage was noticed intraoperatively.The plan of surgery was changed to 3 piece iol, and the second iol was implanted successfully.In the physician¿s opinion, the most likely cause of the iol damage was lens stuck in delivery device.Good patient prognosis.
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Search Alerts/Recalls
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