Device available for evaluation - yes.Returned to manufacturer on: 11/01/2016.Device returned to manufacturer - yes.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection using a 10x microscope magnification showed residues of what appears to be ovd (ophthalmic viscosurgical device) inside the cartridge tube, indicating the device was handled and prepared for surgical use.Stress marks in both sides of the cartridge tube and tip were observed which are typically caused and/or may well appear by the pass of the iol through the cartridge.Also abrasions in the internal section of the tube were observed, that appeared to be related to the insertion hand piece.The cartridge tip was observed deformed and the area of the tip deformation is located at the same side of the abrasion.There was a substance at the cartridge tube that appeared to be viscoelastic.The customer's reported issue for tip deformed was verified.However, no small piece of debris was identified.The reported issue of debris cannot be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During the manufacturing process the operators check the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, dent, bent tip or smash condition.The product was manufactured and released according to specification.Labeling review: the directions for use (dfu) were reviewed.The directions for use (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.All pertinent information available to abbott medical optics has been submitted.
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