FDA WARNING_LETTER - LasikPlus Vision Center - October 06, 2011

On April 3, 2012, the FDA issued a Warning Letter to LasikPlus Vision Center in Atlanta, Georgia, following an inspection on October 5-6, 2011. The inspection determined the facility is 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 facility's device was found to be misbranded under section 502(t)(2) of the Act, due to failure to furnish required material or information under section 519 and 21 CFR Part 803. A significant violation was the failure to submit FDA Form 3500A or an electronic equivalent to the device manufacturer within ten working days of becoming aware of information suggesting a device caused or contributed to a serious injury, as required by 21 CFR 803.30(a)(2).

Specifically, a Customer Incident and Event Reporting Form dated April 21, 2011, indicated a patient lost more than 2 lines of best corrected visual acuity (BCVA) post-LASIK, which the FDA considers a serious injury per 21 CFR 803.3. The facility's rationale for not reporting, stating the event was due to patient response to post-operative care and not laser equipment, was deemed inadequate by