The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified viscoelastics 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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The device and the lens were returned separated.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been fully advanced outside of the nozzle tip.The nozzle tip has two small aneurysms on the bottom.The lens was returned adhered to a small plastic container.Viscoelastic and a small amount of blood are observed on the lens.One haptic is broken-gusset area (not returned).Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause for the reported event could not be determined.The damage observed to the tip of the device and the intraocular lens (iol) would indicate the lens/plunger were not in a proper position for advancement.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified viscoelastics may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.The directions for use (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.Broken haptics may occur: due to the use of a non-qualified viscoelastic.Material properties of non-qualified viscoelastics 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 viscoelastic 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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