|Trade Name||HEALON SODIUM HYALURONATE|
|Classification Name||aid, surgical, viscoelastic|
|Applicant||PHARMACIA & UPJOHN CO.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|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. ".