Additional information provided in d.9., h.3., h.6., and h.10.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 into the nozzle area and has overrode the lens.The lens was located within the lens loading area.The trailing haptic was folded onto the optic along the left side of the plunger.The leading haptic was positioned underneath the plunger.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.The root cause cannot be determined for the reported event.The used device was evaluated.A plunger override was observed.The lens was in the lens loading area.The plunger override was most likely interpreted as the reported event.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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