It was reported that the cartridge tip was noticed fluted during the implantation of an intraocular lens (iol).Reportedly, the lens touched the patient's eye.No incision enlargement, no sutures were used and no patient injury was reported.Another lens, same model and diopter, was implanted as a replacement.No further information was provided.
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Device available for evaluation, returned to manufacturer on: 01/15/2018.Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed viscoelastic residue only in the cartridge tube.No viscoelastic was observed in the loading zone.No damages were observed in the cartridge tip.The customer's reported complaint was not verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During manufacturing the operators check the neck, tube and tip areas for cracks, flash and other defects.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, flash, 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 could not be verified.All pertinent information available to abbott medical optics has been submitted.
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