Concomitant medical products: intraocular lens (iol) za9003 +20.5 dioptre, serial number (b)(4); amo viscoelastic healon, lot number ub32157; non amo viscoelastic, lot number 026254.(b)(6).Device evaluation: the emeraldc30 cartridge was returned to the manufacturing site for evaluation.Visual inspection at 10x microscope magnification showed evidence of viscoelastic ovd (ophthalmic viscosurgical device) residue inside the cartridge tube/tip, indicating that the device was handled and prepared for surgical use.The cartridge tip was observed deformed.No cracks were observed.Manufacturing records review: the manufacturing records for the cartridge 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.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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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.Reportedly, the doctor also noticed that a piece of the cartridge tip was missing.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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