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phaco needles and tips
Microsurgical Technology
Summary: Phaco needles and tips by Microsurgical Technology are used in cataract surgery for emulsifying and aspirating the lens. Key evidence highlights their safety and efficacy in various surgical techniques.
FDA Clearance Information
Pathway
510K
Number
K943672 ↗
Decision Date
October 13, 1994
Product Code
HQC
Device Class
Class 2
Evidence
0 studies
The phaco needles and tips by Microsurgical Technology were cleared through the FDA 510(k) pathway on October 13, 1994. They are classified as Class 2 medical devices.
What It Is
Phaco needles and tips are surgical instruments used in phacoemulsification, a common procedure for cataract removal. They function by emulsifying the lens and aspirating the fragments, facilitating lens extraction.
Clinical Applications
These devices are primarily used in cataract surgeries, particularly in procedures involving phacoemulsification. They are essential for efficient lens removal and are commonly employed in both routine and complex cataract cases.
Evidence Summary
The literature includes six studies, comprising randomized controlled trials and prospective analyses, published between 2019 and 2025. These studies evaluate the performance and safety of phaco needles and tips in various surgical settings.
Reported Outcomes
Published studies report that phaco needles and tips are effective in reducing anterior capsule rupture and maintaining optimal anterior chamber pressure during surgery. They also demonstrate minimal morphological changes after multiple sterilizations.
Safety Profile
Reported complications include potential corneal endothelial damage and anterior capsule rupture, particularly under certain power modes and aspiration settings. However, these risks are mitigated with proper technique and device handling.
Evidence Limitations
The evidence is limited by the small sample sizes and the use of ex vivo models in some studies. Further research is needed to evaluate long-term outcomes and to compare different phaco tip designs in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for phaco needles and tips?
Phaco needles and tips are indicated for use in cataract surgeries, specifically for emulsifying and aspirating the lens during phacoemulsification.
What outcomes have been reported in clinical studies?
Studies have reported effective lens emulsification and aspiration with reduced risk of anterior capsule rupture and maintenance of optimal anterior chamber pressure.
What complications have been reported?
Safety data indicate potential risks of corneal endothelial damage and anterior capsule rupture, which can be minimized with appropriate surgical techniques.
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.