Model Number AU00T0 |
Device Problems
Failure to Advance (2524); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Evaluation summary: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported a faulty intraocular lens (iol) in a preloaded delivery system.There is no reported patient impact.Additional information was requested.
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Manufacturer Narrative
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Additional information provided in g.1., g.2., h.3., h.6., and h.10.The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The product was returned for analysis and the reported complaint was not observed.No damage was observed on the iol.The device was returned in the blister tray inside 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plunger stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted into the mid nozzle.No damage observed to the device.The correct nozzle confirmed on the device.The lens is returned outside of the device in the blister tray.Solution is dried on both surfaces of the optic and haptics.No damage observed.No root cause identified as no damage was observed to the iol.The iol was returned outside the device.No damage was observed to the device.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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