Device available for evaluation, returned to manufacturer on: 11/30/2017.Device evaluation: the three cartridges were returned at the manufacturing site for evaluation.Visual inspection showed: cartridge #1 had no viscoelastic residue, the wings were observed open.The hinge of the wings was observed as if it was handled.Cartridge #2 had viscoelastic residue near the cartridge tip.Cartridge #3 had viscoelastic residue near the cartridge tip and in the wings.The three cartridge tips were observed with a dent.The customer's reported complaint was verified in the three samples received however, due the condition of the lens received it could not be related to the manufacturing process since the samples were handled.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During manufacturing the operators check the neck, tube and tip areas for cracks.No cracks 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.A search revealed that no additional complaints for this order number have been received.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 and the reported issue was verified.All pertinent information available to abbott medical optics has been submitted.
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