SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000

FDA premarket approval P990080/S002 · decided 2002-09-24

Approval details

PMA number

P990080

Supplement

S002

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000

Generic name

intraocular lens

Applicant

Johnson & Johnson Surgical Vision, Inc.

Date received

2002-09-13

Decision date

2002-09-24

Days to decision

11 days

Decision code

APPR

Product code

HQL

Advisory committee

Ophthalmic

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR A NEW TRADE NAME FOR THE MODEL Z9000 FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS, AND OTHER LENS MODELS WHICH INCORPORATE THE MODIFIED PROLATE ANTERIOR OPTIC SURFACE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECHNIS, WITH Z-SHARP OPTIC TECHNOLOGY AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFI-CATION. THE LENS IS INTENDED TO BE PLACED

510(k) clearances by this applicant