PMA P910071S014

Device: ADATO SIL-O1 5000 SILICONE OIL
Applicant: Bausch & Lomb
PMA number: P910071
Supplement: S014
Product code: LWL
Decision date: 2012-08-31
Generic name: Fluid, intraocular
Approval order statement: APPROVAL FOR THE LABELING CHANGES TO YOUR DIRECTIONS FOR USE (DFU). THE DFU WAS REVISED TO INCLUDE SAFETY INFORMATION REGARDING THE USE OF CO2 LASERS IN INSTANCES WHERE SILICONE OIL MAY HAVE MIGRATED OUT OF THE EYE AND FORMED LESIONS IN THE CONJUCTIVA OR EYELID.

Current openFDA PMA Record#

Device: ADATO SIL-O1 5000 SILICONE OIL
Applicant: Bausch & Lomb
PMA number: P910071
Supplement: S014
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2012-08-31
Decision code: APPR
Date received: 2012-08-10
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE LABELING CHANGES TO YOUR DIRECTIONS FOR USE (DFU). THE DFU WAS REVISED TO INCLUDE SAFETY INFORMATION REGARDING THE USE OF CO2 LASERS IN INSTANCES WHERE SILICONE OIL MAY HAVE MIGRATED OUT OF THE EYE AND FORMED LESIONS IN THE CONJUCTIVA OR EYELID.