L V Prasad Eye Institute (LVPEI), India’s leading research and teaching eye hospital, received ISO 13485:2016 certification for the manufacture of BostonSight SCLERAL and PROSE (prosthetic replacement of the ocular surface ecosystem) lenses.
The certificate was given following the review done by the British Standards Institute (BSI). The new ISO certification ensures that the LVPEI’s quality management system meets current global regulatory requirements that are specific to the medical device industry.
Speaking on the occasion, Dr Gullapalli N Rao, Founder and Chair, L V Prasad Eye Institute said, “These special type of contact lenses offer the promise of relief for people afflicted with many problems of the cornea not treatable otherwise. We are delighted that we could make this service available in India.”
He further added that the ISO 13485 certification is a testament to LVPEI’s commitment and reflects rigorous and risk-based approach to development and commercialisation.
The BostonSight SCLERAL and PROSE lens manufacturing facility was established at LVPEI in 2017 in collaboration with Boston Foundation for Sight with an aim to increase the access of these specialized lenses to patients in underserved geographies. These lenses restore visual function, support healing, reduce symptoms, avoid corneal transplantation in some cases and improve quality of life for patients suffering with ocular surface disease, corneal disease, injury or damage.
The facility has served more than 1,500 patients across India and will soon start catering to patients in South-East and Middle-East Asia.
Speaking about BSI’s role, Venkataram Arabolu, Managing Director, BSI Group India said, “BSI is honoured to be the partner of choice and in helping LVPEI deliver global quality using systems. The humanitarian purpose of the organisation makes our service become even more important as we contribute in a small way to a much larger cause.”
Scleral lenses are commonly known for their use in patients with Stevens-Johnson syndrome, keratoconus, corneal grafts, chemical and thermal burn injuries, and ocular pemphigoid, among other uses. However, the increased spotlight on scleral lenses has led to their use in more number of patients with severe dry eyes due to Sjögren’s syndrome, autoimmune diseases, chronic graft-versus-host disease, post-LASIK dry eye, and irregular astigmatism.