The device with the lens was returned loose in a bag.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has advanced the lens to mid-nozzle.The plunger was engaging the trailing optic edge.The plunger position was acceptable.The trailing haptic was folded in on the optic.The leading haptic was extended.The distal haptic tip was at the tip exit.The device tip was severely bent.The device damage was located ahead of the lens and cut haptic.This damage and the cut leading haptic would suggest that the damage was introduced during a potential attempt to extract the lens from the tip of the device.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.No problems are observed with the plunger, lens and haptic positions in the device.The positions are acceptable.Straight leading haptics are not a product malfunction.This is an acceptable position per the diagrams provided in the dfu.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The manufacturer internal reference number is: (b)(4).
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