A healthcare professional reported that while injecting the preloaded intraocular lens (iol) during a cataract removal with iol implant procedure, the haptic of the iol snapped/sheared off and got caught in the wound when the iol was 75% injected.It was noted that the iol seemed to have been in the right position when initially inserting.The haptic was removed using a mushroom instrument, and an anterior vitrectomy was performed due to vitreous leak presumably caused during removal of the damaged lens.A multipiece iol was implanted instead.It was noted that the procedure took about 40 minutes longer than anticipated.Additional information has been requested.
|
Product evaluation: the device and the lens were returned separated.The plunger is oriented correctly.Inadequate viscoelastic is observed in the device.The plunger has been retracted to mid-nozzle.Viscoelastic is observed on the lens.Both haptics are broken-gusset area.The optic is cut into two pieces, typical of a removal.Viscoelastic was not provided; it is unknown if the qualified product was used.The root cause could not be determined for the broken haptic.The lens was returned outside of the device.The plunger was retracted upon return.The plunger position in relation to the broken haptic during advancement cannot be determined.The dfu (directions for use) instructs: after the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 description of the event may indicate the plunger was not fully advanced to allow the haptic to release from the device.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds (ophthalmic viscosurgical devices) may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.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.Any of the above listed causes alone, or in combination, may create the reported event.(b)(4).
|