đź“‹ FDA Reference
Laminar Flow Phaco TIPS
Abbott Medical Optics
Summary: Laminar flow phaco tips are specialized surgical instruments used in cataract surgery to emulsify and remove the eye's lens. Ophthalmologists use them in clinical settings to improve surgical precision and outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111882 ↗
Decision Date ?
November 7, 2011
Product Code ?
HQC
Device Class ?
Class 2
Evidence ?
0 studies
The laminar flow phaco tips by Abbott Medical Optics received FDA clearance through the 510(k) pathway on November 7, 2011. It is a Class 2 device under product code HQC.
What It Is
Laminar flow phaco tips are designed for use in phacoemulsification, a common technique in cataract surgery. These tips help in the emulsification of the eye's lens by using ultrasonic vibrations. The laminar flow design aims to enhance fluid dynamics during surgery, potentially improving efficiency and reducing thermal damage to surrounding tissues.
FDA-Cleared Indications
- Use during phacoemulsification cataract surgery to emulsify and remove the eye's natural lens.
- Use in patients undergoing cataract extraction when removal of the cloudy natural lens is indicated.
Clinical Applications
- Emulsification of the natural lens during cataract extraction.
- Aspiration and removal of lens material during phacoemulsification.
- Use with a compatible ophthalmic phacoemulsification system in an operating room or ambulatory surgery center.
Practical Considerations
- The tip must be compatible with the specific phacoemulsification handpiece and system being used.
- Tip size and design should be selected according to the surgical technique, lens characteristics, and patient anatomy.
- The tip is used under direct microscopic visualization with irrigation and aspiration controlled by the phacoemulsification system.
- Handling, cleaning, sterilization, and reuse must follow the manufacturer's labeling; some tips may be intended for single use.
- This is an ophthalmic surgical instrument and is not intended for MRI procedures or use in blood vessels.
Frequently Asked Questions
What is laminar flow phaco tips used for?
They are used in cataract surgery to emulsify and remove the eye's lens.
What specialties typically use this device?
Ophthalmologists typically use this device in cataract surgeries.
What are the FDA-cleared indications?
The device is indicated for use in cataract surgery to assist in lens removal.
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.