The device and the lens were returned loose and separate in biohazard bags.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.The posterior of the tip at the wound guard has an aneurysm that extends into a split through the tip end.Stress is also observed.The anterior surface of beveled tip is bent backwards (flattened) as if placed on its end on a hard surface.The lens was returned inside a small blue dish like container inside the bag.Solution was observed on the lens.The posterior optic surface has a small scrape mark near the edge.No other damage observed.The root cause for the complaint of ¿resistance with pushing lens through cartridge¿ cannot be determined.The device and lens were returned separately.The nozzle tip has an aneurysm and a has split on the bottom right.This damage would indicate the lens and/or plunger were not in a proper position for advancement.Excessive force would have been necessary to cause this type of atypical damage.The lens was also damaged.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 broken haptic or other negative outcome.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified viscoelastics may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.Other damage was observed to the upper portion of the nozzle tip (bent back).This damage may have occurred due to the device being returned unsecured.The manufacturer internal reference number is: (b)(4).
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