This envelope must have been an unpleasant one to open. Following an inspection of Alcon Inc.’s Aliso Viejo site in California, the agency wrote a stinging warning letter to the company citing a number of serious shortfalls in its activities, not least he placing of its LenSx laser devices onto the market without FDAs required approval of updated software.
The FDA’s letter, which can be found here starts off with the relatively painful stuff about failure to adequately implement Corrective and Preventive Actions (CAPAs). In fact it seems that devices that failed in inspection were not then being subjected to CAPAs at all.
Then things get a bit more serious because it looks like FDA has concluded that the company has been marketing certain of its laser products outwith any PMA for them.
The citation notes that “specifically, the Alcon LenSx Laser System was cleared via K101626, with operating software version 2.02. Your firm has since made multiple revisions to the software, and the LenSx Laser System was running software version 2.13 at the time of the inspection. FDA reviewed your software changes from version 2.02 to version 2.13 and determined that some changes are significant with respect to your original premarket clearance submission and may affect the safety and efficacy of the device. A new 510(k) is required for these changes.”
Closing with the really scary words, the letter says Alcon must “correct the violations addressed in this letter.”
Furthermore it says that; “Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.”
So Alcon has fifteen days in which to write back to the FDA with its specific steps taken to right these wrongs.