Only the used device was returned loose in the carton.The plunger lock and the lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.No damage was observed to the device.The lens was not returned in the device.A qualified viscoelastic was indicated.The product investigation could not identify a root cause.Only the used device was returned.The plunger was retracted.It cannot be confirmed if the lens and plunger were in a proper position for advancement per the provided diagrams in the instruction for use (ifu).The plunger was retracted.The plunger position in relation to the lens during advancement cannot be determined.The ifu instructs: after the lens has been advanced to the nozzle line,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, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.The manufacturer internal reference number is: (b)(4).
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