Polyethersulfone (PES) haptic monofilament provides capability for higher temperature fabrication and sterilization of multi-piece IOLs.
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.
- 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 PES haptics the visual appearance of bilayer blue PMMA haptic monofilament.
- PES haptics may be attached to optic parts using conventional techniques. Safety and effectiveness of IOL haptic parts and lens assemblies using PES monofilament must be determined by the IOL manufacturer.
Safety and effectiveness of IOL haptic parts and lens assemblies using PES monofilament must be determined by the IOL manufacturer.
Biocompatibility test results exhibited in Biogeneral's FDA Device Master File Amendments are available upon request.
Customers must determine the suitability and fitness of Biogeneral products for their application.