[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25518]


[[Page Unknown]]

[Federal Register: October 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0339]

 

IOLAB Corp.; Premarket Approval of the Models LI30U, LI32U, and 
LI41U SOFLEXTM Ultraviolet-Absorbing Silicone 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 IOLAB Corp., Claremont, CA, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the Models LI30U, LI32U, and LI41U SOFLEXTM ultraviolet-
absorbing silicone posterior chamber intraocular lenses. After 
addressing the concerns of the Ophthalmic Devices Panel, FDA's Center 
for Devices and Radiological Health (CDRH) notified the applicant, by 
letter of September 2, 1994, of the approval of the application.

DATES: Petitions for administrative review by November 14, 1994.

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, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Donna L. Rogers, Center for Devices 
and Radiological Health (HFZ-463), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-2053.

SUPPLEMENTARY INFORMATION: On October 8, 1991, IOLAB Corp., Claremont, 
CA 91711, submitted to CDRH an application for premarket approval of 
the Models LI30U, LI32U, and LI41U SOFLEXTM ultraviolet-absorbing 
silicone posterior chamber intraocular lenses. The devices are 
intraocular implants and are indicated for primary implantation for the 
visual correction of aphakia in persons 60 years of age or older where 
a cataractous lens has been removed by extracapsular cataract 
extraction. The lenses are intended to be placed in either the ciliary 
sulcus or capsular bag.
    On May 20, 1993, the Ophthalmic Devices Panel of the Medical 
Devices Advisory Committee, an FDA advisory committee, reviewed and 
recommended disapproval of the application. The concerns of the panel 
have been adequately addressed by IOLAB Corp. in subsequent submissions 
to FDA. On September 2, 1994, CDRH approved the application by a letter 
to the applicant from the Director of the Office of Device Evaluation, 
CDRH.
    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 (21 
U.S.C. 360e(g)), 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 procedures 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 
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 November 14, 1994, file 
with the Dockets 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 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: October 3, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-25518 Filed 10-13-94; 8:45 am]
BILLING CODE 4160-01-F