Advisory Committees

Ophthalmic Devices Panel – March 17, 2000

BRANCH UPDATES

DIAGNOSTIC AND SURGICAL DEVICES BRANCH

Morris Waxler, Ph.D. – Chief

On February 23, 2000, FDA approved the premarket approval application (PMA) P990027, the Bausch & Lomb Technolas 217 scanning laser for the treatment of myopia: -1.00 to -7.00D of SPH and up to < -3.00 D CYL using laser in situ keratomileusis (LASIK).

Currently there are 29 PMA documents under review. Manufacturers submitted 14 IDEs (25 documents) for clinical studies, mostly, but not exclusively, for refractive lasers. Sponsor-investigators submitted 11 IDEs (15 documents) for clinical trials for refractive lasers. Eight pre-market notifications (510k) were reviewed.

INTRAOCULAR AND CORNEAL IMPLANTS BRANCH

Donna R. Lochner – Chief

PMA APPROVALS:

February 3, 2000 - Allergan, Inc. - PMA P980040

Sensar™ Soft Acrylic UV-Absorbing Posterior Chamber Intraocular Lens Model AR40.

This lens was not reviewed at a Panel meeting because the clinical issues were substantially similar to issues previously reviewed by the Panel. However during the clinical study, epithelial cell ongrowth to the anterior surface of the IOL was observed at a rate of 9.2%. FDA required that the company continue to monitor this phenomenon in their ongoing three-year study; however, the company had shown that the lens was reasonably safe and effective, and an approval order issued.

February 23, 2000 – Alcon Laboratories – PMA http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p990023

Cellugel™ hydroxypropylmethylcellulose ophthalmic viscosurgical devices

This viscoelastic was not reviewed at a Panel meeting because the clinical issues were substantially similar to issues previously reviewed by the Panel.

Other Updates:

The Chief of the Intraocular and Corneal Implants Devices Branch, Ms. Donna Lochner, has accepted a 6-month detail as Deputy Director of the Division of General, Restorative, and Neurological Devices effective March 27, 2000.

PMA PRESENTATION

PMA P970043/Supplement 7 – Autonomous Technologies, Inc.

ATC LADARVision® Excimer Laser System for the reduction or elimination of hyperopia from 0 to +6.00 Diopters of sphere and up to –6.00 Diopters of astigmatism at the spectacle plane.

Panel Recommendation by vote: Approvable with conditions, 8-0 (Unanimous)

The conditions of approval:

Full Range of the hyperopic astigmatism and spherical hyperopia treatment to be determined pending FDA evaluation of 9 month data.

Labeling Recommendations

Include patient symptom categories of worse and significantly worse than pre-operative symptoms

Include unsatisfied and very unsatisfied patient data using consumer friendly language

Include quality of vision categories of worse and significantly worse than pre-operative quality of vision.

Include eye dryness rates post-operatively

Revise the Patient Information Booklet regarding information on the loss of best spectacle corrected visual acuity

Include data on the induction of cylinder of greater than or equal to 1 diopter in spherical hyperopes

Highlight the declining predictability over time in eyes with greater than 4 diopters of mean refractive spherical equivalent (MRSE)

Highlight the declining uncorrected visual acuity (UCVA) over time in eyes with greater than 4 diopters of MRSE.

Include a statement that insufficient data are available for the assessment of the safety and effectiveness of retreatment outcomes

Address patient data with respect to age and hormonal replacement therapy.

Include a statement regarding the unknown effects of race (study only done on Caucasians)

Include data on the frequency of the loss of BSCVA greater than or equal to two lines in the various strata.

Include a statement that the risks of refractive instability increase in patients with 2 or more lines loss of BSCVA.

Include a statement that the treatment zone is 9.0 mm; thus, flap size should allow for it.

Include patient outcomes from within the first week and month of treatment in both the patient and physician information booklets.

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

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)