Product evaluation: the device was returned loose in a bag.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was dried in the device.The plunger has been retracted and was at mid-nozzle.The tip has stress lines observed and excess coating that has torn at the anterior bevel.The device was cleaned for further evaluation.The nozzle was removed.Top coat dye stain testing was conducted with acceptable results.Scrape marks were observed which have caused disruptions to the inner coating.The plunger was removed from the body of the device.No damage was observed to the plunger.The lens was not returned.A qualified viscoelastic was indicated.The specific root cause for the reported event cannot be determined.The tip of the returned device has stress.The interior of the tip was scraped, which caused disruptions to the coating.This damage would only occur if the lens and plunger were not in acceptable positions for advancement.Top coat dye stain testing was conducted with acceptable results.The directions for use (dfu) instructs: after the lens has been advanced to the nozzle line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be ¿out of position¿ can result in a negative outcome.The statement was made that the environment was warm.The temperature was not provided.The dfu instructs to use the pre-loaded delivery system at operating room temperatures between 18° c (64° f) and 23° c (73° f).If the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.(b)(4).
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