Model Number AU00T0 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The manufacturing device history records (dhr) were reviewed and shows that the product met specification prior to release.A product sample has not been received at the manufacturing site.The root cause of the reported event cannot be determined; however, should additional reportable information become available, a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56.The manufacturer internal reference number is: (b)(4).
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Event Description
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A healthcare professional reported that during a cataract procedure, the intraocular lens (iol) unfolded too early while inserting the iol.The surgeon pulled the lens back and replaced the iol.The procedure was completed with an alternate iol.There was no patient harm.
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Manufacturer Narrative
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Additional information has been provided in d.10, h.3, h.6 and h.10.The product was returned for analysis and the reported complaint was not observed.The device was returned loose in the carton.The lens stop and the plunger stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger and the lens have been advanced into the mid nozzle.The plunger is at the trailing haptic/optic edge - correct position.The leading haptic is looped - acceptable position per directions for use (dfu).No problems are observed with the returned device.The plunger, lens and haptic positions are acceptable.The observed looped leading haptic is not a product malfunction.This is an acceptable position per the diagrams provided in the dfu.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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