The device with the lens was returned in the opened carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has advanced the lens toward the fill line and has overrode the lens at mid-nozzle.The plunger tip is on the anterior optic surface.Both haptics are tucked into the optic fold.The nozzle was cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.Viscoelastic was not provided.It is unknown if the qualified product was used.A plunger override was observed.This most likely resulted in the reported complaint of "when pressing plunger a lot of pressure was felt".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.Plunger override may occur: due to rapid advancement faster than the dfu recommend rate.Due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to override the lens.If the device is overfilled with ovd, this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.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.Any of the above listed causes alone, or in combination, may create the reported event.Top coat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: (b)(4).
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