FDA WARNING_LETTER - The Lasik Vision Institute - June 24, 2011

On December 16, 2011, the FDA issued a Warning Letter to The Lasik Vision Institute (LVI) following an inspection from June 16-17 and 24, 2011, at their Bellevue, Washington facility. The inspection determined LVI is a medical device user facility subject to Medical Device Reporting (MDR) regulations (21 CFR Part 803) for its ophthalmic lasers used in LASIK procedures.

LVI's devices were found to be misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act due to failure to furnish required material or information under section 519 of the Act and 21 CFR Part 803. Significant violations included the failure to develop, maintain, and implement adequate written MDR procedures as required by 21 CFR 803.17. Specific deficiencies noted were: lack of an effective date for the "Medical Device Reporting Procedure," absence of a standardized review process for reportability decisions and responsible parties, insufficient instructions for timely and complete submission of FDA Form 3500A (including 10-day/5-day reports and all known information), missing instructions for transmitting reports to the correct FDA address, and inadequate description of documentation and record-keeping requirements.

LVI was required to take prompt action to correct these violations and notify the FDA in writing within fifteen