Device available for evaluation? yes, returned to manufacturer on 8/28/2017.Device returned to manufacturer? yes.Device evaluation: the returned 1mtec30 cartridge was received inside a pouch in a bag with a zxr00 lens case.The cartridge was observed under the microscope at 10x magnification, and residues of what appears to be viscoelastic were observed only in the cartridge tube.Viscoelastic residues were not observed in the loading zone of the cartridge.The cartridge tube was observed broken by one side with part of the lens out.A lens was observed stuck in the cartridge tip with part of the haptic out.The complaint was verified; however, the cartridge breakage could appear to be caused by the pushrod handpiece due the scarce amount of viscoelastic observed.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu provide the customer with proper usage instructions and guidelines.Conclusion: 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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