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phaco tips for phaco fragmentation machines
Oasis Medical
Summary: Phaco tips by Oasis Medical are used in phacoemulsification machines for cataract surgery. Key evidence highlights variability in energy output and efficiency differences based on tip design.
FDA Clearance Information
Pathway
510K
Number
K943379 ↗
Decision Date
October 11, 1994
Product Code
HQC
Device Class
Class 2
Evidence
0 studies
The phaco tips by Oasis Medical were cleared by the FDA via the 510(k) pathway on October 11, 1994. They are classified as Class 2 medical devices under product code HQC.
What It Is
Phaco tips are surgical instruments used in phacoemulsification machines to fragment and remove cataracts. They function by delivering ultrasonic energy to emulsify the lens, facilitating its removal.
Clinical Applications
Phaco tips are commonly used in cataract surgeries, particularly in procedures requiring precise emulsification of the lens. They are essential in modern ophthalmic surgeries to ensure efficient lens removal.
Evidence Summary
The literature includes six studies ranging from 1998 to 2025, encompassing various study types such as RCTs and prospective analyses. These studies investigate the efficiency, thermal output, and safety of different phaco tip designs.
Reported Outcomes
Published studies report that the design of phaco tips can significantly impact the efficiency of lens fragment removal and thermal energy output. Variability in outcomes is noted based on tip diameter and bevel orientation.
Safety Profile
Reported complications include the presence of metallic foreign bodies post-surgery and potential corneal endothelial damage. These issues are linked to the design and use of phaco tips during procedures.
Evidence Limitations
Current evidence is limited by variability in study designs and small sample sizes. Further research is needed to standardize outcomes and explore long-term safety implications of different phaco tip designs.
Frequently Asked Questions
What are the clinical indications for phaco tips?
Phaco tips are indicated for use in cataract surgeries to emulsify and remove the lens.
What outcomes have been reported in clinical studies?
Studies report variability in efficiency and thermal output based on phaco tip design and size.
What complications have been reported?
Safety data indicate potential for metallic foreign bodies 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.