Advisory Committees
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. |
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| Existing data should be reanalyzed for pigment dispersion and increased intraocular pressure with respect to the minority cohort subset |
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| Recalculate the cumulative clinically significant adverse events/adverse reactions | |
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Strengthening the labeling with the following (partial list):
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| 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. |
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Strengthening the labeling with the following (partial list):
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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)
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