• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Advisory Committees

  • Print
  • Share
  • E-mail

Ophthalmic Devices Panel Advisory Committee Meeting Brief Summary for February 5-6, 2004

DIVISION UPDATES
A. Ralph Rosenthal, M.D.
Division Director

Dr. Rosenthal made the following statement: The Agency strongly recommends that ALL companies schedule with FDA a pre-PREMARKET APPROVAL APPLICATION (PMA) meeting to discuss accountability, stability, safety & efficacy tables, even if they previously have submitted numerous PMA’s. This will help ensure a better submission and one that will be less likely to result in a “Not Filing” decision or result in significant major deficiencies.

Dr. Rosenthal also noted that the Chief of the Intraocular and Corneal Implants Branch, Ms. Donna Lochner will be on a 6-month detail serving as the Deputy Director in the Division of Cardiovascular Devices.


BRANCH UPDATES

INTRAOCULAR AND CORNEAL IMPLANTS BRANCH
Donna R. Lochner, Chief

Two PMAs have been approved since the last panel meeting on October 3, 2003.

P010059 – Approved October 23, 2003 - Morcher GmbH

Reviewed at the January, 2002 Panel Meeting

The endocapsular tension ring is indicated for the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in adult patients undergoing cataract extraction with intraocular lens implantation. Conditions associated with weak or absent zonules may include primary zonular weakness (e.g. Marfan’s syndrome), secondary zonular weakness (e.g., trauma or vitrectomy), cases of zonulysis, cases of pseudoexfoliation, and Marchesani’s syndrome.

P030002 – Approved November 14, 2003 – Eyeonics (formerly C&C Vision) CrystaLens™ Accommodating Intraocular Lens.

Reviewed at the May, 2003 Panel Meeting

The CrystaLens ™ is intended for primary implantation in the capsular bag of the
eye for the visual correction of aphakia in adult patients in whom a cataractous
lens has been removed and is intended to provide near, intermediate, and
distance vision without spectacles. The CrystaLens™ provides approximately one
diopter of monocular accommodation.


DIAGNOSTIC AND SURGICAL DEVICES BRANCH
Everette T. Beers, Ph.D., Chief

PMA Approvals
Three PMAs have been approved since the last meeting on October 3, 2003:

Approved October 7, 2003

P020050 Wavelight Allegretto Laser Myopia + Astigmatism
Ms. Jan Callaway team leader
Approved Indication: LASIK correction of myopia of up to -12 D with or without astigmatism of up to –6 D

Approved October 10, 2003

P030008 Wavelight Allegretto Laser Hyperopia + Astigmatism
Ms. Jan Callaway team leader
Approved Indication: LASIK correction of Hyperopia up to +6.00D sphere w/up to +5.00D Cyl, w/ MRSE up to + 6.00D

Approved October 10, 2003

P990027/S6 B&L Zyoptix
Ms. Daryl Kaufman team leader
Approved Indication: Wavefront-guided LASIK correction of myopia of up to -7 D with up to –3 D of astigmatism and with manifest refractive spherical equivalent of up to –7.5 D

Premarket Notification (510(k) Clearances

There were 36 510(k)s cleared during 2003.


PANEL DELIBERATIONS – FEBRUARY 5, 2004

The panel then discussed PMA P030028. The PMA has been submitted by OPHTEC USA for their ARTISAN™ Phakic Intraocular lens.

The lens is indicated: For the reduction or elimination of myopia in adults with myopia ranging from greater than -5 to less than -2 diopters (D) with less than 2 D of astigmatism at the spectacle plane for patients with documented stability of refraction for the prior 6 months as demonstrated by a spherical equivalent change of less than or equal to 0.50 D.

Panel Recommendation by vote: Approvable with Conditions, 7 to 6 vote

Conditions of Approval

Included: Limiting the anterior chamber depth to >3.2mm
  Limiting the dioptric range of treatment from >-9 to - 20 diopters (D) of myopia
  Agency should determine age and minimum corneal endothelial cell count
allowable for implantation of the lens.
  Existing data should be reanalyzed for pigment dispersion and increased
intraocular pressure with respect to the minority cohort subset
  Recalculate the cumulative clinically significant adverse events/adverse reactions
 

Strengthening the labeling with the following (partial list):

  • Statement – trauma is a risk factor for IOL dislocation
  • Statement – long term effect to corneal endothelial cells has not been
    established.
  • Delete statements in draft labeling that refer to “improved” visual acuity
    improved” contrast sensitivity
  • Clarify glossary terms in the patient brochure
  • List the adverse events on a per eye and per person basis
  • Statement – When pupil size is greater than the optic size there may be
    visual aberrations
  • Statement – Physicians should perform contact lens refraction to improve
    the accuracy of the IOL selection for higher myopes.
  A postmarket study should be performed for 2-3 years to evaluate the incidence of
retinal detachments, lens explants, cataract formation



PMA PRESENTATION – FEBRUARY 6, 2004

The panel then discussed PMA P010018/S005. The PMA has been submitted by Refractec, Inc. for their ViewPoint™ Conductive Keratoplasty (CK) System

The device is indicated: For the temporary spherical treatment in the non-dominant eye of presbyopic emmetropes or presbyopic hyperopes to achieve a myopic refractive target (-1.00 to -2.00 diopters (D)), i.e., overcorrection to create a myopic endpoint for near vision.

Panel Recommendation by vote: Approvable with conditions (12 votes – unanimous)

Conditions of Approval

Included: Changing the indications statement to include an intended range of hyperopic
refractive correction of +1.00 to +2.25 D of effect.
 

Strengthening the labeling with the following (partial list):

  • Insert – graph showing the regression of the treatment effect over time for
    all eyes, emmetropic eyes only, and hyperopic eyes only.
  • Insert – data on the induction of astigmatism effect of the surgery
  • Statement – There are no data available on retreatments.
  • Information – Efficacy of the spot patterns (8, 16, 24, 32) vs. intended
    Correction
  • Statement – There are no data available on eyes with prior refractive
    surgery
  • Warning – Monovision may affect depth perception
  • Precaution – Patients with a history of glaucoma, steroid-responsive
    intraocular pressure (IOP), or having an IOP >21mm Hg.
  • Contraindication for the procedure: Prior radial keratotomy (RK).
  • Clarification needed: Difference between terms “temporary” and
    “non-reversible” effect.

 

CLOSING ANNOUNCEMENT

The next Ophthalmic Devices Panel meeting is on March 5, 2004 from 9 am to 4 pm at the Hilton Washingtonian DC North, Gaithersburg, MD. There will be a general issues discussion surrounding the use of intraocular lenses for correction of presbyopia after clear lens extraction. Further information is available on the FDA website.

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)

Neal R. Gross and Co., Inc.
1323 Rhode Island Avenue, NW
Washington, DC 20005-3701
(202) 234-4433 (voice) (202) 387-7330 (fax)
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)

Advisory Committee Meetings Database