If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.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 investigations 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.All pertinent information available to abbott medical optics has been submitted.
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