Model Number PCB00 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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If implanted, give date: not applicable, implant not performed.If explanted, give date: not applicable, explant not performed.All pertinent information available to abbott medical optics has been submitted.
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Event Description
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It was reported that after the tip of the cartridge (model pcb00) was inserted into the patient's eye, the surgeon noted a burr at the tip of the cartridge.The cartridge was removed from the eye without any incident.Another pre-loaded lens (same pcb00 model) was inserted without any difficulty.No incision enlargement and no patient injury.No further information was provided.
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Manufacturer Narrative
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Device available for evaluation?: yes, returned to manufacturer on 11/30/2017.Device returned to manufacturer?: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The plunger was observed in advanced position and locked.The cartridge was correctly engaged into the lower body of the pcb00 device.No assembly error and/or defect related to manufacturing process was observed.Visual inspection at 10x microscope magnification showed a lack of lubricant material in the device.The lens was observed stuck at cartridge tube.Dent/distortion was observed on cartridge tip.There was no flash observed.The reported issue of tip deformed was verified.However, the condition of the returned sample is consistent with a product that was handled and prepared for the surgical process.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation there is no indication of a product quality deficiency and the reported issue was verified.All pertinent information available to abbott medical optics has been submitted.
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Search Alerts/Recalls
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