Additional information: device available for evaluation, returned to manufacturer on 4/11/2018.Device evaluation: the preloaded intraocular lens (iol) was returned to the manufacturing site for evaluation.The cartridge component was observed correctly engaged into lower body of the pcb00 device.Some traces of viscoelastics and / or body fluids related to the eye are observed only at the tip of the cartridge; directions for use include to completely fill the viewing window with ovd.The cartridge is observed cracked the tip is deformed due to the crack; the reported issue was verified.The plunger component was observed in advanced position.No assembly defects are observed on the device.Visual inspection with microscope magnification was performed.Based on the visual evaluation of the returned unit, it could not be determined that the cause of the issue reported is related to the manufacturing process.No product quality deficiency was identified.The customer's reported complaint was verified.Manufacturing records review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.A search on complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) was reviewed.The 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 johnson & johnson surgical vision, inc.Has been submitted.
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