đź“‹ FDA Reference
Laminar Flow Phaco TIPS and Irrigation Sleeve 21g Reusable
Abbott Medical Optics
Summary: The laminar flow phaco tips and irrigation sleeve are used in cataract surgery to emulsify and remove the lens. Ophthalmologists use this device in surgical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K121721 ↗
Decision Date ?
October 15, 2012
Product Code ?
HQC
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on October 15, 2012. Manufactured by Abbott Medical Optics, it is classified as a Class 2 device under product code HQC.
What It Is
The laminar flow phaco tips and irrigation sleeve are surgical instruments used in phacoemulsification, a common technique for cataract removal. The device facilitates the emulsification of the eye's lens using ultrasonic energy, allowing for its removal through a small incision. The laminar flow design helps optimize fluid dynamics during surgery, enhancing safety and efficiency.
FDA-Cleared Indications
- For use during phacoemulsification cataract surgery.
- For ultrasonic emulsification and removal of the natural crystalline lens.
- For use with compatible ophthalmic phacoemulsification systems and accessories.
Clinical Applications
- Emulsification of the natural lens during cataract extraction.
- Removal of fragmented lens material through a small corneal incision.
- Fluid irrigation around the phaco tip during cataract surgery.
- Use in ophthalmic surgical settings with a compatible phacoemulsification console.
Practical Considerations
- The listed configuration is a reusable 21-gauge phaco tip with a laminar-flow irrigation sleeve.
- Confirm compatibility with the specific phacoemulsification console, handpiece, tubing and surgical accessories before use.
- Reusable components require cleaning, inspection, sterilization and handling according to the manufacturer’s instructions for use.
- The device is intended for ophthalmic surgery and should not be used for applications outside its labeling.
- MRI safety depends on the materials and configuration; the device should be removed from the MRI environment unless its labeling specifically establishes MR safety or conditional use.
Frequently Asked Questions
What is laminar flow phaco tips used for?
It is used for emulsifying and removing the lens during cataract surgery.
What specialties typically use this device?
Ophthalmologists specializing in cataract surgery use this device.
What are the FDA-cleared indications?
The device is indicated for use in cataract surgery to emulsify and remove the lens.
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.