PMA P810031S024

Device: HEALON SODIUM HYALURONATE
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S024
Product code: LZP
Decision date: 2002-07-25
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR MODIFICATION OF THE "PRECAUTION" SECTION OF THE PACKAGE INSERT TO INCLUDE THE FOLLOWING: "BEFORE INITIATING PHACOEMULSIFICA-TION, USE IRRIGATION/ ASPIRATION TO CREATE A FLUID-FILLED SPACE ABOVE THE LENS. THIS REDUCES THE RISK OF INITIAL VISCO-OCCULSION OF THE PHACO TIP OR THE IRRIGATION LINE WHICH COULD CAUSE PHACO TIP HEATING."

Current openFDA PMA Record#

Device: HEALON SODIUM HYALURONATE
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P810031
Supplement: S024
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2002-07-25
Decision code: APPR
Date received: 2002-07-10
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATION OF THE "PRECAUTION" SECTION OF THE PACKAGE INSERT TO INCLUDE THE FOLLOWING: "BEFORE INITIATING PHACOEMULSIFICA-TION, USE IRRIGATION/ ASPIRATION TO CREATE A FLUID-FILLED SPACE ABOVE THE LENS. THIS REDUCES THE RISK OF INITIAL VISCO-OCCULSION OF THE PHACO TIP OR THE IRRIGATION LINE WHICH COULD CAUSE PHACO TIP HEATING."