SCLERAL and PROSE manufacturing Lab at L V Prasad Eye Institute awarded ISO 13485

SCLERAL and PROSE manufacturing Lab at L V Prasad Eye Institute awarded ISO 13485
Dr. Gullapalli N Rao, Founder-Chairman (6th from left), LV Prasad Eye Institute (LVPEI) receiving the ISO 13485:2016 certification from Mr. Venkataram Arabolu (7th from left), Managing Director, British Standards Institute; on behalf of LV Prasad Eye Institute, for the manufacture of BostonSight SCLERAL and PROSE lenses, following review by the British Standards Institute (BSI), today at LV Prasad Eye Institute. Also seen (L-R) are Mr. Bhaskara Murthy, Sr. Business Development Manager, BSI; Mr. Srinivas Duggirala, Branch Head - Hyderabad, BSI; Dr. Ashutosh Richhariya, Associate Director, LVPEI; Ms. Aparna Dhurjati, Asst Manager - Trainings, BSI; Dr. Ajeeta Nyola, Associate Director, LVPEI; Dr G Chandra Sekhar, Vice-Chair, LVPEI and Mr. Ramam Atmakuri, Executive Vice-Chair, LVPEI.

Hyderabad, September 13, 2019: LVPrasad Eye Institute
(LVPEI), leading research and teaching eye hospital, has received ISO 13485:2016
certification
for the manufacture of BostonSight SCLERAL and PROSE (prosthetic
replacement of the ocular surface ecosystem
) lenses following review
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.

Commenting
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.”

A
commitment to quality is central to LVPEI’s vision of providing excellent and
equitable eye care to all those in need. ISO 13485certification is a testament
to LVPEI’s commitment and reflects rigorous and risk-based approach to
development and commercialization.

The
Boston Sight SCLERAL and PROSE lens manufacturing facility was establishedat
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 patientsacross India and will soon start catering
to patients in South-East and Middle-East Asia.

Mr. 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.”

What
are Scleral lenses

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.

About
L V Prasad Eye Institute

According to a press note The L V Prasad Eye Institute (LVPEI) was established in 1987 at Hyderabad as a not-for-profit, non-government, public-spirited, comprehensive eye care institution. LVPEI is governed by two trusts: the Hyderabad Eye Institute and the Hyderabad Eye Research Foundation. The Institute is a World Health Organization Collaborating Centre for Prevention of Blindness and a Global Resource Centre for VISION 2020: The Right to Sight initiative.

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