Implant and explant dates: if implanted or explanted, give date: not applicable as this is not an implantable device initial reporter phone number: (b)(6).Device manufacture date(s): unknown, because the lot number was not provided device evaluation: although the customer initially reported one cartridge with the tip deformed, four cartridges were returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed some residues of what appears to be viscoelastics on the returned cartridges.Stress marks in both sides of the cartridge tube and tip was observed which are typically caused and/or may well appear by the pass of the intraocular lens through the cartridge.The cartridge tip was deformed.The customer's reported issue of tip deformed was verified on the four returned cartridges.Manufacturing records review: the lot numbers were not available therefore the manufacturing records 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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