📊 Evidence-Based Reference
Medisiss Phacoemulsification TIPS Needles
Surgical Instruments Service And Savings
Summary: The medisiss phacoemulsification tips needles are used in cataract surgery to emulsify and aspirate the lens. Key evidence highlights their efficiency and safety in various surgical techniques.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K030179 ↗
Decision Date ?
January 24, 2003
Product Code ?
NKX
Device Class ?
Class 2
Evidence ?
0 studies
The medisiss phacoemulsification tips needles were cleared through the FDA 510(k) pathway on January 24, 2003. Manufactured by Surgical Instruments Service And Savings, they are classified as Class 2 devices.
What It Is
The medisiss phacoemulsification tips needles are surgical instruments designed for use in cataract surgery. They function by emulsifying and aspirating the cataractous lens, facilitating its removal.
FDA-Cleared Indications
- For use in cataract surgery to emulsify and aspirate the crystalline lens.
- For use with compatible phacoemulsification equipment during removal of cataractous lens material.
Clinical Applications
- Emulsification of the cataractous lens during cataract extraction.
- Aspiration of emulsified lens material during cataract surgery.
- Use during divide-and-conquer cataract techniques.
- Use during chopping techniques for cataract removal.
Evidence Summary
The literature includes 10 studies, ranging from randomized controlled trials to in vitro assessments, published between 2019 and 2024. These studies evaluate the efficiency, safety, and optimal usage of phacoemulsification tips.
Reported Outcomes
Published studies report that the medisiss phacoemulsification tips are effective in reducing surgical time and improving emulsification efficiency. Variations in tip size and technique can influence outcomes such as anterior capsule rupture and corneal thickness changes.
Safety Profile
Reported complications include risks of anterior capsule rupture and corneal endothelial damage. These risks vary depending on the surgical technique and tip configuration used.
Evidence Limitations
The evidence is limited by the variability in study designs and the lack of large-scale, long-term clinical trials. Further research is needed to optimize tip configurations and assess long-term safety outcomes.
Practical Considerations
- The tip or needle must be compatible with the phacoemulsification handpiece, tubing, sleeve and console being used.
- Available dimensions and tip designs may differ; selection depends on the surgical technique, incision size and equipment manufacturer specifications.
- The instrument is intended for ophthalmic surgery and should be handled, cleaned, sterilized or disposed of according to its labeling and facility policy.
- This device is not an implant and does not remain in the body after surgery.
- MRI safety is generally not the primary consideration because the instrument is used outside the MRI environment; remove metallic surgical instruments before MRI and follow the applicable product labeling.
Frequently Asked Questions
What are the clinical indications for medisiss phacoemulsification tips needles?
They are indicated for use in cataract surgeries to emulsify and aspirate the lens.
What outcomes have been reported in clinical studies?
Studies report improved surgical efficiency and reduced complications with optimized tip use.
What complications have been reported?
Safety data indicate risks of anterior capsule rupture and corneal endothelial damage.
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.