Model Number ACU0T0 |
Device Problem
Positioning Problem (3009)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A sample device 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 have been no other complaints reported in the lot number.The manufacturer internal reference number is (b)(4).
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Event Description
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A facility representative reported that during an intraocular lens (iol) procedure, the of the injector / plunger went over the iol.The procedure was completed with a back-up lens.There was no patient harm reported.
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Manufacturer Narrative
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The device with the lens was returned.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was advanced to mid-nozzle and has overrode the lens.The lens was located at mid-nozzle.The trailing haptic was folded onto the optic along the left side of the plunger.The leading haptic was extended along the right side of the plunger with the distal haptic tip oriented toward the nozzle tip.The nozzle was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed.And documentation indicated, the product met release criteria.A qualified viscoelastic was indicated.The root cause cannot be determined, for the reported event.A plunger override was observed.The plunger was at mid-nozzle.A qualified viscoelastic was indicated.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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