Device available for evaluation? yes.Returned to manufacturer on: 05/26/2017.Device returned to manufacturer? yes.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed residue of viscoelastic solution on the cartridge, indicating that the unit was handled and prepared for surgical use.Heavy dent/distortions and a crack were observed at the cartridge tip.The customer's reported complaint was verified.Manufacturing records review: the lot number is unknown, therefore the manufacturing records for the cartridge could not be reviewed.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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