HYDROVIEW COMPOSITE HYGROGEL FOLDABLE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR (IOL)

FDA premarket approval P990014/S004 · decided 2003-09-16

Approval details

PMA number

P990014

Supplement

S004

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

HYDROVIEW COMPOSITE HYGROGEL FOLDABLE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR (IOL)

Generic name

intraocular lens

Applicant

Bausch & Lomb, Inc.

Date received

2003-08-25

Decision date

2003-09-16

Days to decision

22 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 HP60M HYDROGEL IOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME "MERIDIAN" AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE OR OLDER WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY EXTRACAPSULAR EXTRACTION METHODS. THE LENS IS DESIGNED FOR IMPLANTATION IN THE CAPSULAR BAG FOLLOWING EXTRACAPSULAR CATARACT EXTRACTION.

510(k) clearances by this applicant