Additional info: additional information was received and a contact name and email address was provided; therefore updated following fields: (b)(6).Occupation: other health care professional.Other occupation: health case assistant.Device available for evaluation? yes.Returned to manufacturer on: 03/31/2017.Device returned to manufacturer? yes.Device evaluation: the preloaded delivery system, model pcb00, was returned at the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed that the pushrod tip protruded through the cartridge tube creating a hole near the cartridge tip.The intraocular lens (iol) was observed stuck at the cartridge tube.The customer's reported event was verified.Manufacturing records review: the manufacturing records for the intraocular lens 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.All pertinent information available to abbott medical optics has been submitted.
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