Model Number ACU0T0 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Capsular Bag Tear (2639)
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Event Date 11/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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A sample product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There are no other complaints in the lot.(b)(4).
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Event Description
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A nurse reported that during an intraocular lens (iol) implant procedure, the lens stuck in injector and then went into the eye tearing the posterior capsular wall.The lens was removed and an anterior vitrectomy was performed.Another lens was then implanted.In a follow up, the reporter indicated that the issues associated with the event had resolved.
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Manufacturer Narrative
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The device and the lens were returned inside an opened pouch inside a bag.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger was retracted to mid-nozzle.No damage was observed to the device.The lens was adhered in solution to a small piece of tape inside the opened pouch.One haptic is broken in the gusset area.The broken portion was not returned.The optic is torn/cut into two portions.The nozzle was cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.A qualified viscoelastic was used.The root cause cannot be determined for the complaint of "lens stuck in injector/capsular tear".The lens was returned outside of the device with broken haptic damage.The optic was torn/cut into two portions similar in appearance to insertion and removal.The reported condition and the observed broken haptic damage may indicate the lens was not in a proper position for advancement per the provided diagrams in the dfu.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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