PMA P940007S005

Device: CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS
Applicant: Advanced Medical Optics, Inc.
PMA number: P940007
Supplement: S005
Product code: HQL
Decision date: 1999-07-30
Generic name: intraocular lens
Approval order statement: Approval for changes to the Warning Section of the lens package insert. Specifically: "When implanting a lens with a smaller optic (less than or equal to 5.5mm), it is recommended that capsulorhexis, with a diameter smaller than the lens optic, be performed. A thorough cortical cleaning before lens insertion is also recommended."

Current openFDA PMA Record#

Device: CEEON MODEL 912 FOLDABLE INTRAOCULAR LENS
Applicant: Advanced Medical Optics, Inc.
PMA number: P940007
Supplement: S005
Product code: HQL
Generic name: intraocular lens
Decision date: 1999-07-30
Decision code: APPR
Date received: 1999-07-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for changes to the Warning Section of the lens package insert. Specifically: "When implanting a lens with a smaller optic (less than or equal to 5.5mm), it is recommended that capsulorhexis, with a diameter smaller than the lens optic, be performed. A thorough cortical cleaning before lens insertion is also recommended."