PAUL® Glaucoma Implant
PAUL® Glaucoma Implant is a glaucoma drainage device designed to treat glaucoma by regulating intraocular pressure in the patient’s eye and preventing further progression of the disease. The device is constructed entirely from medical implantable grade silicone. This device has a length of 44.9mm, width of 23mm and an extraocular plate surface area of 342.1mm2.
This product is designed for implantation in patients with medically uncontrollable glaucoma and poor surgical outcomes. This includes but is not limited to: neovascular glaucoma, aphakic/pseudophakic glaucoma, patients who have failed conventional surgery, congenital glaucoma and secondary glaucoma due to uveitis, epithelial downgrowth, etc.
July 2017: PAUL® Glaucoma Implant has received CE mark clearance by the European Commission (EC).
November 2017: Health Sciences Authority (HSA) has approved that our product – PAUL® Glaucoma Implant, has demonstrate the quality, safety and performance for inclusion in the Singapore Medical Device Register.
May 2018: Therapeutic Goods Administration (TGA) has approved our product – PAUL® Glaucoma Implant, for inclusion in the Australian Register of Therapeutic Goods.
PAUL® Glaucoma Implant patent updates:
- U.S. Patent No. – US 9,808,374 B2
- Chinese Patent No. – ZL 201580010268.6
- Singapore Patent No. – 11201603540P
- Japan, Europe and India – Pending
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