It was reported that during handling but prior to insertion, the doctor noticed the tip having a bent bevel.In the past, the doctor noted similar issues; it can be either bent in or out.He would evaluate the condition of the bent and decided whether to discard the device or proceed with the procedure.In this case, the doctor continued with the procedure and noted that there was no damage done to the lens or the insertion wound.
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Additional information was received and it was learnt the model and serial number of the lens implanted with the reported cartridge, therefore updated.Concomitant medical products: lens za9003, serial number (b)(4).Device available for evaluation? yes.Returned to manufacturer on: 09/06/2016.Device returned to manufacturer? yes.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed evidence of viscoelastic residues, ovd (ophthalmic viscosurgical device) in the cartridge tube, tip, and loading zone.The tip of the cartridge was observed deformed.No crack or broken parts on the cartridge was observed.The customer's reported complaint was verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.During the manufacturing process the operators check the neck, tube and tip areas for cracks.They also check the tip for any melting, roughness, dent, bent tip or smash condition.If any of these conditions are present, the cartridge is rejected.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were 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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