The customer indicated the cartridge was defective as the intraocular lens (iol) was stuck in the delivery device.The inserter plunger went out the back of the cartridge instead of pushing lens out the end.The lens was removed from the eye and replaced with the same model during the same procedure.There was no incision enlargement, no sutures, no patient injury.No additional information was provided to abbott medical optics.
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Device evaluation: evidence of viscoelastic ovd (ophthalmic viscosurgical device) residues was detected inside the cartridge tube, indicating the device was handled and prepared for surgical use.Visual inspection at 10x microscope magnification was performed.A cartridge crack was observed at the cartridge tube/tip that could be related to the hand piece pushrod.The lens was not in the cartridge.The reported device problem codes of iol partially delivered, override, stuck in cartridge, could not be verified; however, a cartridge crack was observed on the returned cartridge.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provide instructions and precautions along with warnings for the proper use and handling of the device.Conclusion: 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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