If implanted, give date: not applicable as this is not an implantable device if explanted, give date: not applicable as this is not an implantable device phone number: (b)(6).Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed no residue of viscoelastic in the cartridge.The cartridge was observed cracked and missing a portion of the cartridge tip.The customer's reported complaint was verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.During manufacturing 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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