# FDA WARNING_LETTER - Alcon LenSx, Inc. - August 02, 2012

Source: https://www.keypedia.com/records/warning_letter/alcon-lensx-inc/ff810373-e18c-4585-8d2c-d790e9c92e7a

> FDA WARNING_LETTER for Alcon LenSx, Inc. on August 02, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Alcon LenSx, Inc.
- Inspection Date: 2012-08-02
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: 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

## Related Officers

- [Mariel Peterson](https://www.keypedia.com/people/mariel-peterson/3b1b72d1-9112-4d0a-b14e-cf709a39a243)
- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.keypedia.com/companies/alcon-lensx-inc/41ae4929-7f7b-4ada-810c-e7234e4ed69d

Office: https://www.keypedia.com/offices/department-of-health-and-human-services/cecfcda4-4afa-4a1f-a7b7-a020b79f9861