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Clinical evaluation of the Unfolder

R Olson, R Cameron, T Hovis

Journal of Cataract and Refractive Surgery

|January 10, 1998

Summary

The Unfolder device is clinically acceptable for implanting AMO PhacoFlex II intraocular lenses (IOLs). It allows controlled implantation through small incisions with no reported adverse events or complications.

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Area of Science:

Ophthalmology
Medical Devices
Surgical Technology

Background:

Cataract surgery often involves intraocular lens (IOL) implantation.
Efficient and safe IOL delivery systems are crucial for surgical outcomes.
The Unfolder is a device designed for IOL implantation.

Purpose of the Study:

To evaluate the clinical acceptability of the Unfolder device.
To assess the Unfolder's performance in implanting specific AMO PhacoFlex II intraocular lenses (IOLs).

Main Methods:

A multi-center study involving 101 patients across six investigational sites in the United States.
Investigators compared the Unfolder to existing IOL implantation systems.
Internal incision sizes were measured before and after IOL implantation.

Main Results:

Investigators rated the Unfolder as clinically acceptable.
Mean internal incision size was 3.0 mm pre-implantation and 3.1 mm post-implantation.
No haptic deformation, optic damage, or Unfolder-related complications were reported.

Conclusions:

The Unfolder is easy to use and provides controlled IOL implantation.
The device facilitates implantation through small incisions (2.7-3.2 mm).
The Unfolder demonstrated safety and efficacy in this clinical evaluation.

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