The device with the lens was returned.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been advanced over the lens to mid-nozzle.The lens is still in the loading area.The trailing haptic is folded in on the anterior optic.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause could not be determined.A plunger override was observed.The plunger position advanced to mid-nozzle with the lens still in the loading area may indicate the plunger was advanced too rapidly.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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