This is not an implantable device.Concomitant medical products: lens ar40, serial number unknown; non-amo viscoelastic, lot unknown.(b)(6).Device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.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 and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.
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It was reported that an intraocular lens (iol) was loaded correctly into the cartridge by an experienced theatre nurse.Reportedly, upon insertion of the lens into the patient's eye, the surgeon noted a ¿milking¿ appearance of the anterior chamber.The surgeon felt that the ¿milking¿ appearance may have been caused by an artefact from the cartridge (sloughing of the coating inside the cartridge).The surgeon performed irrigation/aspiration (ia) but could not remove all of the ¿milking¿ appearance in the anterior chamber.Reportedly, there was no patient injury, but the surgeon was unsure if this effect observed through the microscope will clear on its own, or result in reduced visual acuity/high intraocular pressure (iop) in the patient post-operatively.The cartridge was discarded after surgery.No further information was provided.
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