Inspections, Compliance, Enforcement, and Criminal Investigations
Laser Eye Care of California, LLC 10/26/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
OCT 26 2011
VIA UNITED PARCEL SERVICE
Thomas S. Tooma, M.D.
Laser Eye Care of California, LLC
16255 Ventura Boulevard
Encino, California 91436-2300
Dear Dr. Tooma:
During an inspection of your firm located in Encino, California, on June 8, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility and is subject to the statutory reporting 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). This product is a device because it is intended for the use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or function of the body.
Our inspection revealed that your facility's devices are 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 have an adequate MDR procedure describing an internal system that provides for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements; a standardized review process or procedure for determining when an event meets the criteria for reporting; and timely transmission of complete medical device reports to the manufacturers and FDA, as required by 21 CFR 803.17(a). For example:
1. There are no definitions of what your facility will consider to be a reportable event under 21 CFR Part 803.17. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include additional definitions based on Part 803.3 for the following terms: become aware; caused or contributed; MDR reportable event; as well as definitions for the term reasonably known, found in Part 803.30(b), and the term reasonably suggests, found in Part 803.20(c)(1).
2. The procedure includes a (b)(4) for medical complications associated with LASIK surgeries and includes an (b)(4). This information should only be used as a reference and not as the sole means to make MDR determinations. The information included in the reference limits decision making for reportability. For example, serious injuries should not be limited by means of (b)(4). Per 21 CFR Part 803.3, a death or serious injury that was or may have been attributed to a medical device, or when a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of failure, malfunction, improper or inadequate design, manufacture, labeling or user error, is reportable to FDA.
3. The procedure requires the surgeon or clinical director to (b)(4) and the (b)(4) for determination of a reportable event. However, the procedure fails to provide instructions for completing and submitting the FDA Form 3500A to the device manufacturer or FDA, as required by 21 CFR Part 803.32.
4. The procedure does not include the address for submission of MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
Your firm should take prompt action to correct the violation addressed in this letter. Failure to promptly correct the violation 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 #221455 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/MedicaIDevices/deviceregulationandguidance/guidancedocuments/ucm094529.htm#Where
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.
Seven D. Silverman
Office of Compliance
Center for Devices and