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Specifications
Surgeon Information

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1. Choose Your Patients:

The Best Candidates are:

• Emmetropes and Hyperopes
• Patients with realistic expectations

Avoid Patients with:

• Severe dry eyes
• Ocular infection
• Greater than or equal to one diopter of pre-operative corneal astigmatism
• Severe ophthalmic disease such as macular disease, severe uveitis, severe glaucoma or retinal disease
• Uncontrolled systemic disease e.g. diabetes, hypertension or cardiovascular disease


2. Pre-Surgical Preparation:

• Use normal cataract surgery calculation equation—accurate biometry is IMPORTANT.

• Calculate using a post op aim of emmetropia or -0.25D of myopia.

• Corneal topography essential to determine corneal astigmatism; if present must be corrected.

• Explain post operative recovery in detail and discuss patient expectations in detail. The lens is designed for improved social reading, not a complete freedom from glasses.


3. Recommended Surgical Procedure:
Note: A blue lens was used for visibility purposes only.
1. Correct any underlying astigmatism with Limbal relaxing incisions.
2. Standard phacoemulsification technique.
3. Remove the implant lens from the lens-case, being careful to grasp the lens by the optic (not the haptic).
4. Prepare injector cartridge with viscoelastic.
5. Load the implant so that the positioning nub is lying to the right with the leading haptic.
6. Close the injector cartridge, keeping gentle pressure down on the optic and making sure the optic and haptics are not pinched in the wings of the injector.
7. Load the cartridge into the injector and push the plunger to ensure the implant moves freely in the cartridge.
8. Carefully introduce the loaded injector tip into the anterior chamber (bevel facing down to avoid touching the endothelium), until the opening of the cartridge is beyond the distal pupil margin.
9. Gently inject the lens into the anterior chamber. Rotate the injector counterclockwise if necessary to ensure the IOL remains oriented correctly as it emerges from the cartridge. Ensure the leading haptic is in the bag and the positioning nub is oriented correctly.
10. Gently withdraw the cartridge from the eye as the trailing haptic emerges from the cartridge.
11. Reconfirm that the anterior chamber is deep and, if not, introduce additional viscoelastic material.
12. Using a tapered “pusher,” insert the trailing haptic if protruding from the section and let it drop into the bag.
13. Irrigate out the viscoelastic from the anterior chamber and from behind the IOL.
14. Hydrate the edges of the section to seal it. No sutures are normally required, but if the section appears leaky or the chamber remains shallow a suture may be advisable.

4. Post-Surgical Treatments & Observations:

• Schedule patient visits and medications in the manner normally done for a cataract surgery.
• The patient should be maintained on antibiotic/steroid drops for two weeks.
• Treat even mild dry eye vigorously with ocular lubricants and/or punctal occlusion.
• Positive encouragement of patient is essential throughout post op period. The surgeon should be prepared to impress the positive gains achieved in vision through practical examples.
• Accommodative exercises should be encouraged once post operative inflammation has resolved completely.
• Correct any residual refractive error with appropriate surgical technique after two months.

 
The Tetraflex™ is not currently FDA approved.
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