The product was not returned.A video was provided.There appeared to be trouble advancing the lens.The lens appeared to be misfolded with the edges down.Both haptics were misfolded under the optic.As the lens was advanced, the plunger could be observed under the optic instead of at the optic edge.The optic appeared to be cracked on the right side and gouged in the center due to the plunger underride.Product history records were reviewed and documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.Based on review of the provided video, a plunger underride occurred.The lens continued to be advanced in a misfolded position.The root cause may be related to a failure to follow the dfu.A non-qualified viscoelastic was indicated.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the dfu, only qualified viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the dfu and is not recommended under any circumstance.The dfu 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.The manufacturer internal reference number is: (b)(4).
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