Zeizz CT LUCIA 611PY Instrucciones De Uso página 2

Heparin Surface yellow Hydrophobic Acrylic Posterior
EN
Chamber Intraocular Lens with UV Absorber
Lens is already pre-oriented for insertion:
1. Description: One ZEISS UV light-absorbing Heparin Surface Yellow Hydrophobic Acrylic
Posterior Chamber Intraocular Lens. This lens is intended to correct aphakia. It is made
from an optically clear yellow hydrophobic acrylic material which incorporates an UV-ab-
sorbing component and has a Heparin coating.
• Material: ................................ Yellow hydrophobic acrylic with UV-absorber
• Refractive Index: ...................................................................................1.49
2. Packaging: ZEISS Hydrophobic Acrylic Posterior Chamber Intraocular Lens is supplied
sterile, non- pyrogenic and preloaded in a single use injector. Sterility is assured provided
the blister seal has not been compromised or blister has not been punctured.
3. Indications: Senile cataracts and other forms of cataract. The lens is intended to be
placed in the capsular bag.
4. Contraindications: Careful preoperative evaluation and careful intraoperative clinical
judgment should be used by the surgeon to decide the benefit / risk ratio when implanting
a lens in a patient with any of the following conditions:
1. Chronic uveitis, iritis, iridocyclytis or rubeosis iridis.
2. Congenital bilateral cataracts.
3. Excessive vitreous pressure.
4. Medically uncontrollable glaucoma.
5. Ruptured posterior capsule or zonular separations.
6. Patients with only one eye with potentially good vision.
7. Proliferative diabetic retinopathy.
8. Endothelial corneal dystrophy.
9. Operative vitreous loss.
10. Aniridia.
11. Marked microphthalmos.
12. Recurrent anterior or posterior segment inflammation of unknown etiology.
13. Rubella cataract.
14. Patients with an allergy to heparin should not be implanted with this lens.
15. Implantation of posterior chamber lenses in the anterior chamber has been shown to
be unsafe and should not be performed with posterior chamber lenses.
16. Children.
5. Complications: Potential complications and adverse reactions may include but are not
limited to:
• Lens dislocation
• Hypopyon
• Vitritis
• Intraocular infections
• Transient or persistent glaucoma
• Corneal endothelial damage
6. Instructions for Use:
1. Check the label on the lens box for proper lens model, dioptric power and expiration
date.
2. For best results: use ZEISS OVDs, and ensure that both OVD and the preloaded
instrument are at least 18 °C during use.
3. Remove the blister outside the sterile area. Open the blister in the sterile area and
remove the preloaded ZEISS injection system. Contrary to traditional injection systems,
the ZEISS injection system has the cartridge integrated in the injector.
4. To remove the lens positioning clip, place two fingers at the top of the lens holder and
use your thumb underneath the clip to gently release it. Then lift the clip straight up.
(Fig. 1).
5. Cover the whole lens (Fig.2) and blue plunger tip (Fig.3) with a generous amount of
OVD. Avoid touching the lens and blue plunger tip.
6. Check that the lens is in the correct position, central and secure in the loading
chamber. (Fig. 4).
7. Close the lid of the IOL chamber. (Fig. 5).
8. To advance the lens into the injector tip, gently press the plunger forward and push
the lens into the conical tip of the injector, ensuring the lens moves smoothly forward.
(Fig. 6). Retract the plunger slightly to separate the blue plunger tip from the IOL and
ensure the haptics are properly positioned. The IOL is now ready for implantation.
IMPORTANT: The lens should now be injected straight away. Viscoelastic materials may
lose their lubricity if allowed to stand too long while exposed to air.
9. During injection, press the injector plunger forward and then continuously apply and
release pressure. Continue this "pulsing action", to ensure the IOL advances smoothly.
The IOL will slide smoothly into the eye without pushing the cushion tip past the end
of the injector tip. Pushing the cushion tip through the end could result in a blooming
effect.
10. Carefully position the lens, rotating it if necessary with the aid of a suitable positioning
hook. The compressed haptics recover together with the folded optic body simultane-
ously, within one minute at human body temperature.
Implantation
• Cystoid macular edema
• Wound leakage
• Iris prolapse
• Pupillary block
• Corneal edema
• Deviation from the target refraction