đź“‹ FDA Reference
ceeon heparin surface modified hsm uv light-absorbing posterior chamber iols
Abbott Medical Optics
Summary: The Ceeon Heparin Surface Modified IOLs are intraocular lenses used to replace the eye's natural lens after cataract removal. Ophthalmologists use them primarily in cataract surgery to improve vision.
FDA Clearance Information
Pathway
PMA
Number
P960034 ↗
Decision Date
May 8, 2007
Product Code
HQL
Device Class
Class 3
Evidence
0 studies
The Ceeon Heparin Surface Modified IOLs by Abbott Medical Optics were cleared through the FDA's premarket approval (PMA) pathway on May 8, 2007. This Class 3 device is used in ophthalmic surgeries.
What It Is
The Ceeon Heparin Surface Modified IOLs are posterior chamber intraocular lenses designed to replace the natural lens of the eye following cataract extraction. These lenses are modified with a heparin surface to enhance biocompatibility and reduce postoperative inflammation. Additionally, they absorb UV light, providing protection against UV-related damage.
Clinical Applications
These IOLs are commonly used in cataract surgeries, a procedure frequently performed by ophthalmologists. They are typically implanted in outpatient surgical centers or hospital settings. The lenses are suitable for adult patients undergoing cataract surgery, aiming to restore clear vision by replacing the clouded natural lens.
Indications for Use
The FDA indications note the addition of a sterilizer used in the production of these IOLs. Clinically, this means the lenses are sterile and ready for safe implantation in patients needing lens replacement due to cataracts.
Practical Considerations
The Ceeon Heparin Surface Modified IOLs come in various diopter strengths to accommodate different levels of vision correction. They are compatible with standard cataract surgery techniques and tools. Surgeons should ensure proper lens sizing and positioning for optimal patient outcomes.
Frequently Asked Questions
What is Ceeon Heparin Surface Modified IOLs used for?
These IOLs are used to replace the eye's natural lens after cataract removal to restore clear vision.
What specialties typically use this device?
Ophthalmologists, particularly those specializing in cataract surgery, use these intraocular lenses.
What are the FDA-cleared indications?
The lenses are indicated for use in cataract surgery, with a focus on their sterile production process ensuring safety for implantation.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.