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Only the empty lens carton was returned with the packaging inserts.No peel pouch, lens case, or lens inside a cartridge were returned.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The file indicated the use of a qualified cartridge and handpiece.Two viscoelastics were indicated.Only one is qualified for use with this lens/cartridge combination.It is unknown if the qualified viscoelastic was used.The root cause for the reported "lens did not inject properly" complaint cannot be determined.Only the empty lens carton was returned.The file indicated the use of two viscoelastics.Only one is qualified for use with this lens/cartridge combination.It is unknown if the qualified viscoelastic was used.The instructions for use (ifu) instructs: company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.In addition, the company cartridge ifu has specific lens loading instructions for multipiece lenses.The ifu instructs: use holding forceps to grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge (diagram provided).The lens should be inserted until it is centered with or slightly past the outline etched into the top of the cartridge.Lenses with a 6.5 mm optic diameter may need to be pre-folded for easy entry into the back of the cartridge.Lens may be pre-folded by gently applying pressure to the edge of the lens while holding the central optic with forceps as shown.The trailing haptic will extend from the proximal end of the cartridge.Position the trailing haptic to the left of the haptic post as shown in the detailed view.This will allow the plunger to go past the haptic during the initial advancement of the plunger into the cartridge.Verify the lens is positioned on the bottom surface of the cartridge.The haptic should be maintained to the left of the post when the lens is loaded correctly.Accurate positioning of the lens will decrease the potential for optic and haptic damage.Use the company cartridge at operating room temperatures between 18° c (64° f) and 23° c (73° f).Temperature greater than 23° c (73° f).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 and cause damage.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
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A non-health care professional reported that during an intraocular lens (iol) implant procedure, it was noticed that the haptic broke in half when doctor picked up.The piece inside the company handpiece that usually expels the lens malfunctioned and slid above the lens, which did not allow the lens to expel into the eye.The procedure was completed the same day.Additional information has been requested, yet no new information received.
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