CDSCO Probes Alcon's IOL for Drastically Diminishing Patient's Sight
The Central Drugs Standard Control Organisation (CDSCO) has formed a committee to investigate allegations of quality issues with an intraocular lens (IOL) supplied by Alcon. The Swiss-American company specializes in eye care products, including lenses for cataract surgery.
Specifics of the Complaint Raised by Dr. Vikas Mahatme
Dr. Vikas Mahatme, in a letter addressed to Union Health Minister Mansukh Mandaviya, highlighted concerns regarding a particular Alcon lens. He reported a case where the lens drastically reduced a patient’s vision after implantation in May 2016.
Lens Details: Acrysof Single Piece IOL, Model SA60AT, Power 23.5 D, Length 13 mm, Optic 6 mm, SN-21136985 027.
Patient Affected: Sanjay Bhalme, who received the implant on May 9, 2016.
Dr. Mahatme emphasized that the implanted lens is expected to remain transparent for the patient’s lifetime but reported that the lens had become opaque, significantly impairing the patient’s vision.
Dr. Mahatme Calls for Ministerial Intervention and Action
Dr. Mahatme urged the Union Health Minister to take stringent action against Alcon. He criticized the company’s response to the issue, noting:
"I wish to bring to your kind notice a serious problem with Alcon... It is expected that the lens must remain transparent for the rest of the patient’s life."
He shared his dissatisfaction with Alcon's handling of the matter, particularly during a video conference where he alleged the company demonstrated insensitivity.
Allegations of Disparity in Handling Complaints
Dr. Mahatme pointed out the disparity in how Alcon handles such cases in India compared to Western countries:
"They can do this only in India. Had it been any western country, they would have paid a huge compensation."
He also raised concerns about the possibility of similar issues affecting other patients, calling for immediate action to ensure no further harm and to provide compensation to the affected patient.
Alcon’s Official Response
Alcon issued a statement addressing the investigation and reaffirmed its commitment to patient safety:
"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."
