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i(   DEPARTMENT OF HEALTH & HUMAN SERVICES
     DEPARTMENT OF HEALTH & HUMAN SERVICES                                      Public Health Service
                                                                                Public Health Service

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                                                                               Food and Drug Administration
                                                                               Food and Drug Administration
                                                                               2098 GaitherRoad
                                                                               2098 Gaither Road
                                                                               Rockville MD 20850
                                                                               Rockville MD 20850
                                       JUL 0 1997
                                       JUL I| n 1997

                                    WARNING LETTER
                                    WARNING LETTER




     DeD
     De
     The Food and Drug Administration (FDA) inspected       your medical practice on
     The Food and Drag Administration (FDA) inspected your medical practice on
     June and 3, 1997 and determinedthat you obtainedar unapprovedexcimer laser system
     June 2 and 3, 1997, ,and determined that you obtained an unapproved excimer laser system
           Jerry Tennant,          in March 1996. EdwardSullivan, an engineering     consultant
     from Jerry Tennant, M.D., in March 1996. Edward Sullivan, an engineering consultant with   with
     Exsull, Drexel Hill, Pennsylvania,                         this
                                          originally assembled lasersystemin Dr. Tennant's
     Exsull, Drexel Hill, Pennsylvania, originally assembled this laser system in Dr. Tennant's
                       personnelfrom NeumanMicroTechnologies,              Bow, New Hampshire,
     office and, with personnel from Neuman MicroTechnologies, Inc., Bow, New Hampshire,
     ofFce and,
     helped install this samesystemin your office when it was movedthere in March 1996.
     helped to install this same system in your office when it was moved there in March 1996.
          Sullivan was responsiblefor the installation of the sculpting device which focusesthe
     Mr. Sullivan was responsible for the installation of the sculpting device which focuses the
     Iaserbeam       the patient. This excimer laser systemis a device within ttre meaningof section
     laser beam on the patient. This excimer laser system is a device within the meaning of section
                the FederalFood, Drug and CosmeticAct (the             Excirnerlasersystems
     2010) of the Federal Food, Drug and Cosmetic Act (the Act). Excimer laser systems are
     201(h)                                                                                   are
     ClassItr devices which are required to have in effect an approvedapplication for premarket
     Class III devices which are required to have in effect an approved application for premarket
     approval           or an approvedlnvestigationalDevice Exemption
     approval (PMA) or an approved Investigational Device Exemption (IDE).
     Medical devicesusedby physicians the course their practiceto treat patientsare
     Medical devices used by physicians in the course of their practice to treat patients are
     'marketed" and "held for sale" within the meaningof the Act, and thus, are subjectto the
     "marketed" and "held for sale" within the meaning of the Act, and thus, are subject to the
     provisions of      ikct. Your excimerlasersystemis adulterated   under section501(0(1XB) of
     provisioris of the Act. Your excimer laser system is adulterated under section 501(0(1)(B) of
     the     because it is a ClassIII deviceunder section513(0, which is requiredto havein effect
     the Act because is a Class III device under section 513(f), which is required to have in effect
     an approvedapplication               an approved        and no suchPMA or IDE is in effect
     an approved application for PMA or an approved IDE, and no such PMA or IDE is in effect
              excimer laser. Further, your continued of this deviceto treat patientsis also a
     for your excimer laser. Further, your continued use of this device to treat patients is also a
                                                      use
     violation of the Act.
     violation the Act.

     ln addition, your excimer lasersystemmustcomply with the requirements the Federal
                                                                               of
     In addition, your excimer laser system must comply with the requirements of the Federal
     Performance   Standards laserswhich are found in          21 of the Codeof Federal
     Performance Standards for lasers which are found in Title 21 of the Code of Federal
                   (CFR) parts 1040.10   and 1040.11.
     Regulations, (CFR) parts 1040.10 and 1040.11.
     Regulations,

     Section538(a) the           ChapterV, Subchapter (formerly the RadiationControl for
                                                       C
     Section 538(a)of the Act, Chapter V, Subchapter C (formerly the Radiation Control for
                               1968)prohibits any manufacturer  from certiffing or introducinginto
     Health and Safety Act of 1968) prohibits any manufacturer from certifying or introducing into
     Healthand Safety
     commercelaser productswhich                             standards. This sectionalso prohibits
     commerce laserproducts which do not comply with the standards.Thissection also prohibits
                                             comply
     any manufaeturer   from failure to esiablishand maintainrequiredrecordsor to submit required
     any manufacturer from failure to establish and maintain required records or to submit required
     repons. To date, we havenot received LaserProductReport from Neuman
     reports. To date, we have not received aaLaser Product Report from Neuman
     MicroTechnologies           EdwardSullivanfor this excimerlaser systemas requiredunder
     MicroTechnologies or Mr. Edward Sullivan for this excimer laser system as required under
     cFR 1002.10.
     CFR 1002.10.
Pase2-
Page 2

Please  note that FDA doesnot consideryour excimerlaserto be a customdevice. Section
Please note that FDA does not consider your excimer laser to be a custom device. Section
520(b) the Act establishes conditions,eachof which must be met by a deviceto be a
5200) of the Act establishes five conditions, each of which must be met by a device to be a
                               five
customdevice. The Act's customdevicedefinition requiresthat the devicebe madeto meet
custom device. The Act's custom device definition requires that the device be made to meet
either the specific anatomicalrequirementsof an individual patient or the special needsof an
either the specific anatomical requirements of an individual patient or the special needs of an
                         a practitioner's special needsmay be either an individual anatomical
individual practitioner; a practitioner's special needs may be either an individual anatomical
need a special practice need that is not sharedby other physicians.
need or a special practice need that is not shared by other physicians.
We do not believe the requirementsof your medical practice are unique becausethey are
We do not believe the requirements of your medical practice are unique because they are
sharedby numerous other health professionals. Inaddition, we do not believe your device is
shared numerousother healthprofessionals. In addition, we do not believeyour device is
$esigned meet any specfalanatomicalneedsthat you or an individual patient of yours may
designed to meet any special anatomical needs that you or an individual patient of yours may
have. Accordingly, your laser not a custom device and is not exempthom the requirement
have. Accordingly, your laser isis not a customdeviceand isnot exempt from the requirement
under the      that this device must have an approvedPMA or IDE in effect.
under the Act that this device must have an approved PMA or IDE in effect.
Pleasenotify
Please notify this office within 15 working days of your receipt of this letter as to what, if
                     office within 15          days of               of            to        if
any, actions you are taking, or plan to take, to bring your device into compliance with the
any, actions        are taking, or plan to take, to bring your device into compliance with the
Act. Your response should also clearly state whether or not you have ceased using the device
       Your responseshould also clearly statewhether or not you have ceasedusing the device
   ffeat p{!entg. Failury to immediately and completely ceaseclinical use of the device upon
to treat patients. Failure to immediately and completely cease clinical use of the device upon
receiptof this letter and failure to bring your deviceinto compliancewith the Act, may rezult
receipt of this letter and failure to bring your device into compliance with the Act, may result
   regulatory action             without further notice. Theseactionsinclude, but are not limited
in regulatory action by FDA without further notice. These actions include, but are not limited
    seianre,injunction, and/or civil penalties. Please    note that no extensions the 15 day
to, seizure, injunction, and/or civil penalties. Please note that no extensions of the 15 day
response period will be given.
response  period         be given.

Your response
      response should be sent to the attention of Mary-Lou Davis, Dental, ENT and
               should sent the attention                    Davis, Dental,     and
Ophthalmic DevicesBranch (HFZ-331) at the letterheadaddress. In addition, please send a
Ophthalmic Devices Branch                       letterheadaddress. addition, pleasesenda
copy of your response to Mr. J. Austin Templer, Compliance Officer, U.S. Food and Drug
             response         J. Austin Templer, Compliance                Food and Drug
Administration, 3310       Oak Street,Dallas, Texas75204. If you have further questions,
Administration, 3310 Live Oak Street, Dallas, Texas 75204. If you have further questions,
pleasecontact
please contact Mary-Lou Davis at (301) 594-4613 extensionL27 or FAX: (301) 594-4638.
                                          594-4613extension 127 or FAX: (301) 5944638.

                                       Sincerely yours,
                                       Sincerelyyours,

                                      /-.t    c'ttnr     I r
                                      ( Rt+*"c' DA / 19.t*-
                                        tsft-     t 'Q'r-'
                                       Lillian J. Gill
                                       Lillian J. cill     )
                                       Director
                                       Director
                                       Office Compliance
                                       Offrce of Compliance
                                                   Devicesand RadiologicalHealth
                                       Centerfor Devices and Radiological Health
                                       Center

				
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