Alcon's IOL Faces Probe by CDSCO

The Central Drugs Standard Control Organisation (CDSCO) has established a committee to investigate complaints regarding quality issues with an intraocular lens supplied by Alcon, a Swiss-American pharmaceutical and medical device company specializing in eye care products.

Dr. Viskas Mahatme, in a letter to Union Health Minister Mansukh Mandaviya, raised concerns about a specific Alcon lens that resulted in diminished vision for a patient who received the implant in May 2016.

The lens in question is described as follows: Acrysof Single Piece IOL, Model SA60AT, Power 23.5 D, Length 13 mm, Optic 6 mm, SN-21136985 027.

Dr. Mahatme seeks the minister's intervention to ensure stringent action is taken against the company. He explains, "I wish to bring to your kind notice a serious problem with Alcon, a multinational company that manufactures IOLs for cataract surgery. I have implanted it in one of my patients, Sanjay Bhalme. It is expected that the lens which is implanted must remain transparent for the rest of the patient's life."

Dr. Mahatme shares that he implanted an Alcon IOL in the patient's right eye on May 9, 2016. However, to his surprise, the lens has become opaque, causing a significant decrease in the patient's vision quality. The patient is unable to see if the light comes from the front side. Dr. Mahatme expresses his concern and frustration with the casual and careless attitude of Alcon when he raised the issue with them.

During a video conference meeting with the Alcon team, Dr. Mahatme alleges that they displayed a lack of sensitivity towards the matter. He points out the disparity in how the company handles such issues in India compared to western countries, stating that "they can do this only in India. Had it been any western country, they would have paid a huge compensation."

Dr. Mahatme raises further concerns about the potential occurrence of similar problems in other patients, which could lead to disastrous outcomes. He seeks the intervention of the Union Health Minister to take strict action against the company to prevent any more patients from being affected and to provide compensation to the affected patient.

Alcon issued a statement regarding the matter: "At Alcon, we believe that everyone deserves access to the standard of care when it comes to eye health, regardless of geography, gender, age or socioeconomic status. We are supporting the Healthcare Authority to address this case. We remain committed to the well-being of our patients and maintaining the highest standards of quality and safety for all our products."

*Stay in the loop and make sure not to miss real-time breaking news about ophthalmology. Join our community by subscribing to OBN newsletter now.