PMA P910061S015

Device: LI61AO LENS
Applicant: Bausch & Lomb
PMA number: P910061
Supplement: S015
Product code: HQL
Decision date: 2006-12-06
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL TO ADD A STATEMENT TO THE DIRECTIONS FOR USE THAT THE SOFPORT MODEL LI61 AO IOL HAS PROLATE ASPHERIC SURFACES AND IS DESIGNED TO BE FREE OF SPHERICAL ABERRATIONS, AND TO ADD A FIGURE WITH THE MODULATION TRANSFER FUNCTIONS FOR THE LI61AO AND LI61SE LENSES.

Current openFDA PMA Record#

Device: LI61AO LENS
Applicant: Bausch & Lomb
PMA number: P910061
Supplement: S015
Product code: HQL
Generic name: intraocular lens
Decision date: 2006-12-06
Decision code: APPR
Date received: 2006-08-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO ADD A STATEMENT TO THE DIRECTIONS FOR USE THAT THE SOFPORT MODEL LI61 AO IOL HAS PROLATE ASPHERIC SURFACES AND IS DESIGNED TO BE FREE OF SPHERICAL ABERRATIONS, AND TO ADD A FIGURE WITH THE MODULATION TRANSFER FUNCTIONS FOR THE LI61AO AND LI61SE LENSES.