Alcon, a division of Novartis, received a warning letter from the United States Food and Drug Administration for marketing its updated LensSx cataract laser without the proper regulatory clearance. While an older version of the LensSx does have regulatory approval from the FDA, the company updated the device with new software and other miscellaneous improvements.
In the FDA warning letter, the government watchdog agency also chided the company for not providing adequate proof of how it addresses manufacturing problems.
The company originally received the warning letter on December 3rd of last year. The letter came in response to an inspection at the company’s manufacturing facilities in Aliso Viejo, California, between June 7th and August 2nd of 2012.
According to a spokesman from Alcon, the warning letter does not question the efficacy or safety of the LensSx cataract laser. The spokesman also stated that Abbott’s first FDA-cleared cataract surgery femtosecond laser remains on the market.
Since receiving the warning letter, the company has provided additional information and data to the FDA within the required timeline. On the 11th of February, the spokesman noted that "Alcon received a response from the FDA acknowledging that the corrective actions of the company appear to address the items identified in the warning letter.”
FDA regulators will conduct an additional inspection to make sure that all previously noted issues have been addressed.