Polyethersulfone (PES) haptic monofilament
provides capability for higher temperature fabrication and
sterilization of multi-piece IOLs.
iFLEX PES haptics can be formed on conventional fixtures at appropriately
high temperatures. Loops formed under these conditions have
shown post steam sterilization stability. Typical conditions
for steam sterilization are 121°C at 15 psi for 15 minutes.
Dry heat sterilization typical conditions are 160°C for 120 minutes.
iFLEX PES monofilament is a blue,
fused, bilayer structure. The core colorant is phthalocyaninato
(2-) copper and the outer layer is natural PES. Hue,
chroma, color value and transparency give iFLEX the
visual appearance of bilayer blue PMMA haptic monofilament.
Safety and effectiveness of IOL haptic parts
and lens assemblies using iFLEX PES monofilament
must be determined by the IOL manufacturer.
Biocompatibility test results exhibited
in Biogeneral's FDA Device Master File Amendments are available