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The lens and the damaged device were returned submerged in clear liquid inside a plastic container.The lens was removed and allowed to air dry prior to evaluation.Viscoelastic was observed on the lens.One haptic was broken in the distal tip.The broken haptic tip was not returned.The other haptic has small cracked damage on the anterior and posterior optic/haptic junction area.The optic was torn from the edge toward the optic center.The posterior of the optic has small scrape marks and scratches.The posterior optic has a small cracked area located near the optic edge.The device and plunger were cut in order to fit inside the container.The device was cut at the plunger lock area and the beginning of the lens loading area.The plunger lock was intact in this cut portion of device.The plunger thumb push and plunger tip has also been cut.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause could not be determined for the broken haptic damage and the optic damage.The lens was returned outside of device.The device and plunger were cut by the customer.The plunger position in relation to the broken haptic during advancement cannot be determined.The instructions for use (ifu) instructs: after the lens has been advanced to the ¿fill-to¿ 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.No part of the lens should exit the nozzle prior to insertion through the incision.Once the lens is in position at the ¿fill-to¿ line, it should be implanted within 3 minutes.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.Broken haptics may occur: due to the use of a non-qualified viscoelastic.The use of an unqualified ophthalmic viscosurgical device (ovd) may cause damage to the lens and potential complications during the device preparation and implantation steps.If the operating room temperature is too high (more than 23 degrees celsius or 73 degrees fahrenheit) 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.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).
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