The device and the lens were returned separated.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been retracted to the loading area.A broken haptic with optic material is observe in the nozzle tip.The distal portion is oriented toward the nozzle tip.The lens was returned adhered to the outside of the device on the bottom.The lens is broken at one optic/haptic junction.The lens is cut from the edge to the center.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.Root cause: the root cause may be related to a failure to follow the dfu.A non-qualified viscoelastic was used in the device.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the company iq aspheric intraocular lens with company preloaded delivery system dfu, only qualified viscoelastics ¿ (company) 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 for the company iq aspheric intraocular lens with company preloaded delivery system 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, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.The broken haptic is on the correct side of the plunger.The distal portion is facing the end of the nozzle.The plunger was retracted.The plunger position in relation to the broken haptic during advancement cannot be determined.The haptic position may indicate the plunger was not fully advanced.If the plunger is not fully advanced the trailing haptic may not release properly from the device.Broken haptics may occur: ¿ 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 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.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.¿ if the device is overfilled with ovd as this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.¿ if a straight trailing haptic occurs and it was not properly detected to be out of position.¿ if the plunger is not fully advanced, or if the plunger is allowed to retract, the trailing haptic may not release properly from the device.(b)(4).
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