Alcon LenSx, Inc. – FDA Warning Letter, Aug 2, 2012

On December 3, 2012, the FDA issued a Warning Letter to Alcon LenSx, Inc. following an inspection from June 7, 2012, to August 2, 2012. The inspection revealed that the LenSx Laser System, a medical device, was adulterated under 21 U.S.C. § 351(h) because its manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

A key violation was the failure to establish adequate procedures for corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, the firm's CAPA procedures (Rev. C and D) were not implemented for failures of the LenSx Laser Systems' oscillators. Between September 2011 and April 2012, at least 10 systems failed in-house final testing and 12 experienced out-of-box failures, all attributed to an oscillator issue. Despite these failures requiring a Corrective Action Request (CAR) per the firm's CAPA Decision Matrix, no CAR was initiated. While CAR 12-015 was initiated during the inspection, the firm's response lacked sufficient evidence of proposed corrections and implementation.

Additionally, the devices were found to be adulterated under 21 U