The cartridge is not an implantable device; therefore, not explanted.(b)(6).Device evaluation: the complaint device was not returned.Six emeraldc30 cartridges were returned in their original package.Visual inspection at 10x microscope magnification was performed.All cartridges were returned sealed and unused.No product damage and/or tip defect were observed on the returned units.The reported issue was not verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the product.Conclusion: 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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