It was reported that after the implantation of an intraocular lens (iol), the surgeon noticed some viscous material, described as ''lint'', in the patient's eye.The surgeon believes that the material came from the cartridge.Reportedly, the lens remains implanted and the debris was aspirated from the eye.The patient was reported being alright, no visual issues and no injuries.Both the cartridge and the debris were discarded by the customer.No further information was provided.
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Device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed.A video of the surgery was provided and it was evaluated.During the lens implantation, it was observed a foreign material on the lens.The foreign material was removed from the lens.The customer's reported complaint was verified, however since the cartridge was not returned for inspection, it was not possible to confirm if the condition reported was related to in-line manufacturing practices/processes or a result of the lens being handled by the user.Manufacturing records review: the manufacturing records for the cartridge were reviewed.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 and the reported issue was verified.All pertinent information available to abbott medical optics has been submitted.
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