Advanced Ophthalmic Innovations Pte Ltd (AOI) is a research and development innovation organisation with a heart. Our mission is to develop long-term effective solutions to prevent Glaucoma patients from losing their eyesight. The solution should be accessible and affordable to patients around the world.
We are serious in our work, because patients depend on us to develop the best solution, taking into consideration production cost, technology, and affordability.
Paul® Glaucoma Implant has received CE mark clearance by the European Commission (EC) on the 20 July 2017. This shows that our product has met specific standard of performance, quality, safety and efficacy. As an ISO 13485-certified company, Advanced Ophthalmic Innovations Pte Ltd (AOI) has a quality assurance system that produces ophthalmic implants of the highest quality. The design, development, manufacturing and distribution of Paul® Glaucoma Implant is according to ISO 13485 standards. Paul® Glaucoma Implant has met the following standards:
✔ Directive 93/42/EEC Annex II (excluding Section 4-EC type examination)
✔ EN ISO 13485:2012 – Quality Management System for medical devices
✔ EN ISO 14971 – Application of risk management to medical devices
✔ EN ISO 10993 – Biological evaluation of medical devices
✔ EN ISO 11979 – Ophthalmic Implants; Biocompatibility