APR 3, 2012
VIA UNITED PARCEL SERVICE
Ms. Casi Cleaveland
LasikPlus Vision Center
200 Galleria Parkway
Atlanta, Georgia 30339
Dear Ms. Cleaveland:
During an inspection of your firm located in Atlanta, Georgia, on October 5-6, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility that is subject to the statutory requirements of the Medical Device Reporting (MDR) regulation, found at Title 21 Code of Federal Regulations (CFR) Part 803.
The ophthalmic laser used at your facility to perform Laser-Assisted In Situ Keratomileusis (LASIK) procedures is a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or function of the body.
Our inspection revealed that your facility’s device is misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting. Significant violations include, but are not limited to, the following:
Failure to submit a FDA Form 3500A or an electronic equivalent to the device manufacturer within ten working days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility, as required by 21 CFR 803.30(a)(2). For example, the Customer Incident and Event Reporting Form dated April 21, 2011, for (b)(6), indicated that an EDIR surgery was conducted to remove debris from a patient without detailing the reason for the procedure and the facility’s rationale for considering the event to be not reportable.
The information included for (b)(6) suggests that, after the LASIK procedure, the patient lost more than 2 lines of best corrected visual acuity (BCVA). FDA believes that the loss of 2 lines of BCVA represents an impairment of vision function. Therefore, the information included for (b)(6) meets the definition of a serious injury found at 21 CFR 803.3, which should have been reported by your facility to the device manufacturer. There is no evidence that the complaint was forwarded to the manufacturer.
We reviewed your facility’s response and conclude that it is not adequate. The response states that your facility does not consider adverse events as reportable when the event is not the result of laser equipment, but rather the patient’s response to post-operative care. Your facility should be aware that 21 CFR 803.3 states that, if a medical device may have been a factor in a serious injury, then such event meets the criteria for reportability.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, MDR Policy Branch, White Oak Building 66, 10903 New Hampshire Avenue, Room 3208, Silver Spring, MD 20993. Refer to the Unique Identification Number #255515 when replying. If you have any questions about the contents of this letter or wish to discuss MDR reportability criteria or schedule further communications, please contact: MDR Policy Branch at (301) 796-6670 or by email at MDRPolicy@fda.hhs.gov.
If your facility wishes to submit MDR reports via electronic submission, it can follow the directions stated at the following URL: http://www.fda.gov/MedicalDevices/deviceregulationandguidance/guidancedocuments/ucm094529.htm#where1
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and
Accessed online 4/18/2012 at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm300497.htm