[Federal Register Volume 61, Number 136 (Monday, July 15, 1996)]
[Notices]
[Pages 36887-36888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17825]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0221]


Alcon Laboratories, Inc.; Premarket Approval of Acrysof 
Models MA60BM and MA30BA Ultraviolet-Absorbing Soft Acrylic Posterior 
Chamber Intraocular Lenses

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Alcon Laboratories, Inc., Fort Worth, 
TX, for premarket approval, under the Federal Food, Drug, and Cosmetic 
Act (the act), of Acrysof Models MA60BM and MA30BA 
ultraviolet-absorbing soft acrylic posterior chamber intraocular 
lenses. After reviewing the recommendation of the Ophthalmic Devices 
Panel, FDA's Center for Devices and Radiological Health (CDRH) notified 
the applicant, by letter of December 22, 1994, of the approval of the 
application.

DATES: Petitions for administrative review by August 14, 1996.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Donna L. Rogers, Center for Devices 
and Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2053.

SUPPLEMENTARY INFORMATION: On May 28, 1993, Alcon Laboratories, Inc., 
Fort Worth, TX 76134-2099, submitted to CDRH an application for 
premarket approval of Acrysof Models MA60BM and MA30BA 
ultraviolet-absorbing soft acrylic posterior chamber intraocular 
lenses. The devices are posterior chamber intraocular lenses and are 
indicated for replacement of the human lens to achieve visual 
correction of aphakia in patients 60 years of age and older when 
extracapsular cataract extraction or phacoemulsification are performed. 
These lenses are intended for placement in the capsular bag.
    On May 20, 1994, the Ophthalmic Devices Panel of the Medical 
Devices Advisory Committee, an FDA advisory committee, reviewed and 
recommended approval of the application. On December 22, 1994, CDRH 
approved the application by a letter to the applicant from the Director 
of the Office of Device Evaluation, CDRH.

[[Page 36888]]

    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under part 12 (21 CFR 
part 12) of FDA's administrative practices and regulations or a review 
of the application and CDRH's action by an independent advisory 
committee of experts. A petition is to be in the form of a petition for 
reconsideration under Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner 
shall identify the form of review requested (hearing or independent 
advisory committee) and shall submit with the petition supporting data 
and information showing that there is a genuine and substantial issue 
of material fact for resolution through administrative review. After 
reviewing the petition, FDA will decide whether to grant or deny the 
petition and will publish a notice of its decision in the Federal 
Register. If FDA grants the petition, the notice will state the issue 
to be reviewed, the form of the review to be used, the persons who may 
participate in the review, the time and place where the review will 
occur, and other details.
    Petitioners may, at any time on or before August 14, 1996, file 
with the Docket Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in the brackets in the 
heading of this document. Received petitions may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: June 21, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-17825 Filed 7-12-96; 8:45 am]
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