(b)(6).Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection using a 10x microscope magnification showed residues of viscoelastic solution (ovd) on the cartridge indicating that the unit was handled and prepare for surgical use.A crack was observed at the cartridge tip area.The customer's reported complaint was 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.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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