It was reported that during the implantation of an intraocular lens (iol), the surgeon noticed under the microscope that the tip of the cartridge had a deformed shaft and it began to stretch and crack as the lens advanced through it.They heard the cartridge cracking.The cartridge channel broke open inside the patient¿s eye.The surgeon had to use a second instrument to advance the lens into the implant position and also to extract the cartridge.Reportedly, a small piece of particle matter was noticed and was aspirated following the lens implant.There were no adverse effects.No injury to the patient's eye and no surgical or medical intervention was required.The patient's outcome was reported being as expected.No further information was provided.
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Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Viscoelastics residues are detected at the cartridge tip.Visual inspection at 10x microscope magnification was performed and 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 iol thru the cartridge.The cartridge is cracked and tip is deformed.There are no particle / debris detected on the returned device.The customer's reported complaint for debris/particles was not verified, however tip deformed was verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed and there were no associated nonconformity reports.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.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.The documentation shows that the production order was manufactured and released according to specifications.All pertinent information available to abbott medical optics has been submitted.
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