Laser Eye Care of California, LLC – FDA Warning Letter, Jun 8, 2011

On June 8, 2011, an FDA inspection of Laser Eye Care of California, LLC, identified the firm as a medical device user facility subject to Medical Device Reporting (MDR) regulations (21 CFR Part 803). The ophthalmic laser used for LASIK procedures is a medical device. The firm's devices are misbranded under section 502(t)(2) of the Act because the firm failed to furnish required material or information under section 519 of the Act and 21 CFR Part 803.

Significant violations include the failure to have an adequate MDR procedure as required by 21 CFR 803.17(a). Deficiencies include: 1. Lack of definitions for reportable events, including "become aware," "caused or contributed," "MDR reportable event," "reasonably known," and "reasonably suggests." 2. The procedure's reliance on a (b)(4) and (b)(4) for medical complications, limiting reportability decisions and not encompassing all serious injuries as defined by 21 CFR Part 803.3. 3. Failure to provide instructions for completing and submitting FDA Form 3500A to manufacturers or FDA, as required by 21 CFR Part 803.32. 4. Omission of the correct address for MDR report submissions.

The FDA requires prompt corrective action to