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Ophthalmic Devices Panel Advisory Committee Meeting Summary for July 20, 2001

DIVISION UPDATES

A. Ralph Rosenthal, M.D. - Director

Dr. Rosenthal announced the departure of Deputy Director, Nancy C. Brogdon from the Division and her promotion to Director of the Division of Reproductive, Abdominal, and Radiological Devices.

He also announced the change of status of Division Associate Director, David M. Whipple from Associate Director to Deputy Director.

BRANCH UPDATES

VITREORETINAL AND EXTRAOCULAR DEVICES BRANCH
James F. Saviola, O.D. - Chief

PMA approvals

  • Vistakon (lenefilcon a) soft hydrophilic contact lens indicated for daily and extended wear up to 7 days.

    Approved Feb. 16 -2001

Premarket Notification 510(k) Clearances

ORTHOKERATOLOGY (ORTHO-K) LENSES

  • K010109 Paragon Fluroperm 151-OK,
    February 28, 2001 - labeling references 60-OK study
  • K003932 Polymer Tech Boston EO, and
    K003933 Polymer Tech Boston Equalens II, February 16, 2001
    labeling for both references Contex's clinical study, the Polymer XO material was cleared in August 2000

There are now a total of 6 daily wear ortho-k lenses cleared. Since the Contex Airperm lens and the Paragon Fluoroperm 60-OK and HDS - OK were already cleared based on data generated from an original clinical studies.

LENS CARE PRODUCTS

Last meeting it was reported that Opti-Free EXPRESS Multi-Purpose Disinfecting Solution manufactured by Alcon received two marketing clearances to modify their directions to be a "No-Rub" care product.
The first clearance in July 2000 was for lenses replaced 30 days or less, followed by a second clearance in October to remove the 30 day limitation to include soft contact lenses prescribed on any replacement schedule.

There are now two more care products that have received a "No-Rub" clearance for lenses replaced 30 days or less.

  • K003252 cleared on Feb. 21, 2001 for Allergan Complete Multipurpose solution
  • K003345 cleared March 26, 2001 for Ciba Vision's AO Sept One-Care peroxide solution with the addition of a surfactant to the peroxide.

As with all of these clearances, there's wording in the labeling to advise users that additional products or procedures such as rubbing their lenses may be recommended by their eye care provider.


INTRAOCULAR AND CORNEAL IMPLANTS BRANCH
Donna R. Lochner - Chief

PMA Approvals

  • Staar Surgical P000026 AquaFlow Collagen Glaucoma Drainage Device, Model CGDD-20
    reviewed by Panel in November 2000.

    approved 7/12/01

  • Pharmacia P990080 CeeOn Edge Foldable UV-absorbing PC IOL Model 911A

    approved 4/5/01

Other

  • Anika Therapeutics Inc. P000046, licensing PMA in which Bausch & Lomb provided reference rights to P810025 (Amvisc), sodium hyaluronate viscoelastic was approved 4/18/01. This means that Anika has approval to distribute and manufacture the Amvisc sodium hyaluronate under their label. At this time, Anika did not request distribution under the Anika label; instead they received approval for Staar Surgical Company to distribute the product as Staarvisc II sodium hyaluronate.
DIAGNOSTIC AND SURGICAL DEVICES BRANCH
Everette T. Beers, Ph.D. - Acting Branch Chief

PMA Approvals

  • P930016/S12 -- VISX LASIK Hyperopic Astigmatism (+5.0 D sphere; +3.0 D Cylinder)

510(k) Clearances

  • K011199 (June 2001) -- B&L Proview Eye Pressure Monitor, formerly the Fresco Phosphene Tonometer. OTC for home use. The tonometer is utilized on the closed eyelid and requires the subjective response of the perception of a phosphene.
  • Keratome LASIK Guidance (on the CDRH website). Keratomes may now use "LASIK" in their promotion. This is a change from previously when these Class I devices were not allowed to advertise or be indicated for the Class III indication of "LASIK".
  • Wave Front Analysis Autorefractometers (Aberrometers) are Exempt with Limitations. ProCode: NCF. Exempt 510(k) devices do not have to submit premarket notification (510(k)) to FDA; but, in accordance with Section 513(i)(1)(E) of the Act, these exempt aberrometers MUST carry the Warning in their labeling that "The safety and effectiveness of using the data from (this device) have not been established for determining treatments involving higher order aberrations of the eye such as coma and spherical aberrations." See also 510(k) K000637 for the Limitations warnings, on the FDA website at http://www.accessdata.fda.gov/cdrh_docs/pdf/k000637.pdf .

Other

  • Forward all consumer calls to the Office of Communication, Education, and Radiation Programs (OCER), Div of Small Manufacturers Assistance (DSMA), at 800-638-2041 or via e-mail DSMA@CDRH.FDA.GOV

 

PMA PRESENTATION

PMA P010019 - CIBA Vision Corporation, A Novartis Company

Focus® Night and Day (lotrafilcon A) soft contact lens

Indication for Use: for the optical correction of refractive ametropia in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism. The lenses may be prescribed for extended wear for up to 30 nights of continuous wear between removals for cleaning and disinfection or for disposal of the lens, as recommended by the eye care professional.

Panel Recommendation by vote: Approvable with Conditions (unanimous)

Conditions of Approval

Modification of the Indications Statement
  • Remove the indication for patients who have experienced dryness in contact lens wear. The sponsor may include this data on dryness in the labeling if they desire.

    Modifications to the Labeling

  • Include data that is specifically concerned with the incidence of giant papillary conjunctivitis (GPC) with the Focus® Night and Day soft contact lens as compared to the Acuvue control lens.
  • Include information
    • on the timing of corneal infiltrates in the test and control lens;
    • on patients who experience an infiltrates subsequently having a six times increase in the rate for a second occurrence and advising that more caution is required with these patients;
    • on the fact that aphakic patients were not tested in the study; therefore, there is no documented evidence that the aphakic patient would not be at risk;
    • on the annualized rates of corneal infiltrates;
    • on the fact that the risk of microbial keratitis in the Focus Night and Day lens has not been established and that post market studies are underway to determine the risk; and,
    • advising patients to call Ciba Vision if they experience any serious adverse events such as microbial keratitis.

Post-approval Requirements

  • A post market study should be undertaken to establish the rate of microbial keratitis.

CLOSING ANNOUNCEMENT

The next Panel meeting will be a one day meeting on September 21, 2001

Contact: Sara M. Thornton, Executive Secretary
(301) 594-2053, ext.127; e-mail smt@cdrh.fda.gov

TRANSCRIPTS MAY BE PURCHASED FROM: (Written Request Only)
Miller Reporting Company, Inc.
507 C Street, N.E.
Washington, D.C. 20002
(202 546-6666
or
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

EXECUTIVE SUMMARY MAY BE PURCHASED FROM:
(Written Request Only)
Food and Drug Administration
Freedom of Information Staff (FOI)
5600 Fishers Lane, HFI-35
Rockville, MD 20852
(301) 827-6500 (voice) (301) 443-1726 (fax)

CDRH Advisory Committee Database