Device evaluation: the cartridge was not returned at the manufacturing site as it was discarded by the customer; therefore product testing could not be performed and the customer's reported complaint could not be verified.A video and photos of the surgery were provided and they were evaluated.It could be seen that a substance, during the visual inspection of the cartridge (before use), was removed from the emeraldc30 cartridge by the surgeon with his hands/gloves.The surgeon proceeded in the process of the preparation of the product and performed the implantation of the iol.In the video, debris was observed at the edge of the iol during implantation.The debris was also removed by surgeon after the iol implantation.Throughout the manufacturing processes there are various cleaning operations and 100% visual inspection under the microscope that would have identified and discarded a device with a similar material or substance.Based on the evidence observed, it was not possible to confirm if the foreign material was related to the manufacturing process, as the reported device was handled and prepared for a surgical procedure.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.In addition, sterilization records were reviewed.Sterilization was processed and no deviations were found that affects the sterility of the device.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 johnson & johnson surgical vision, inc.Has been submitted.
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