iFLEX® PES
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.
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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 Amendment are available
upon request.
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