|
Device | HEALON SODIUM HYALURONATE |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive suite 200 Irvine, CA 92618 |
PMA Number | P810031 |
Supplement Number | S024 |
Date Received | 07/10/2002 |
Decision Date | 07/25/2002 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
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." |