CRYSTALENS SE, MODEL AT-45 SE

FDA premarket approval P030002/S004 · decided 2005-09-08

Approval details

PMA number

P030002

Supplement

S004

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

CRYSTALENS SE, MODEL AT-45 SE

Generic name

Lens, intraocular, accommodative

Applicant

Bausch & Lomb, Inc.

Date received

2005-07-05

Decision date

2005-09-08

Days to decision

65 days

Decision code

APPR

Product code

NAA

Advisory committee

Ophthalmic

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PHYSICIAN'S LABELING: CHANGE IN THE MODEL NUMBER AND TRADE NAME; CHANGE IN DIRECTIONS FOR USE TO FACILITATE PROPER INSERTION AND ORIENTATION OF THE LENS; AND, CHANGE IN THE EXISTING RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CRYSTALENS SE (MODEL AT-45 SE) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA SECONDARY TO THE

510(k) clearances by this applicant