The intraocular lens (iol) was loaded normally with no issues.When it was handed to the surgeon, he was unable to advance the iol.It was very tight.When the iol was pushed through, the inserter plunger left a mark on the iol.The surgeon also noticed debris was coming off the end of the cartridge when inserting the lens into the eye.A follow-up was made to clarify if the debris was inserted into the eye along with the iol.It was confirmed that the debris went into the patient¿s eye as the iol went into the eye.The surgeon did not explant the lens but instead aspirated out the debris.There was no patient injury and no vitrectomy.The incision had to be made larger than 2.4 millimeters.The procedure was completed successfully.The events occurred over 2 unknown surgery dates for a total of 8 cartridges.No additional information was provided to abbott medical optics.Note: this report captures the event for cartridge 8 of 8.
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Correction: in the initial mdr, it was inadvertently reported that the product had been returned.Further review noted the product had not been returned.The following have been corrected: device available for evaluation: no.Device returned to manufacturer: no.Device evaluation: the product was not returned for evaluation.Therefore, the customer's reported issue could not be verified.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 instructs the customer in the proper use 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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