|
Device | ADATO SIL-O1 5000 SILICONE OIL |
Generic Name | Fluid, intraocular |
Regulation Number | 886.4275 |
Applicant | BAUSCH & LOMB 50 Technology Drive Irvine, CA 92618 |
PMA Number | P910071 |
Supplement Number | S014 |
Date Received | 08/10/2012 |
Decision Date | 08/31/2012 |
Product Code |
LWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |