New Delhi: The Central Drugs Standard Control Organisation has formed a committee to probe complaints of quality issues of an intraocular lens supplied by Alcon, a Swiss-American pharmaceutical and medical device company specialising in eye care products.
The development follows a complaint by a Maharashtra-based ophthalmologist and former Rajya Sabha MP Dr Vikas Mahatme, sources in the Union Health Ministry told ThePrint.
In a letter to Union Health Minister Mansukh Mandaviya last month, Mahatme alleged an Alcon lens had led to diminished vision in a patient on whom the implant was done in May, 2016. ThePrint has a copy of the letter.
The details of the lens against which the complaint has been made are: Acrysof Single Piece 1OL; Model- SA60AT; Power-23.5 D. Length 13 mm; Optic 6 mm; SN- 21136985 027.
Mahatme said the lens, which was implanted in the patient’s right eye six years ago, had gone opaque now.
“I was shocked to see this when the patient came to me in November, 2022,” Mahatme wrote.
“He had diminished quality of vision. He cannot see if the light comes from the front side. Unfortunately, his left eye is already blind and now he has compromised vision in the right eye too (sic),” the letter read.
The ex-parliamentarian also wrote that he raised the issue with Alcon executives, but found their attitude “casual and careless”.
Mahatame said he was concerned that similar problems may have occurred in other patients.
“To avoid this and also to compensate for the vision of the patient, I seek your intervention in this matter so that stringent action should be taken against the company,” said the letter to Mandaviya.
“This will ensure that no more patients are affected in this way. The company can’t take Indian patients so lightly (sic).”
Replying to a query by ThePrint on the issue, a written statement by the pharmaceutical company read, “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 to maintaining the highest standards of quality and safety for all our products,” it further said.
This copy has been updated to reflect the written statement given by Alcon.
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