PMA P980040S053

Device: SENSAR 1-PIECE LENS MODEL AAB00
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S053
Decision date: 2014-11-15
Approval order statement: CHANGE FROM MACHINED TO A MOLDED IOL EDGE BLOCKER, CHANGE IN CYCLE TIME FOR THE IOL TUMBLING PROCESS, ADDITION OF A COSMETIC INSPECTION FOLLOWINGSTERILIZATION, CHANGE IN TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF IOLS, ANDNEW ULTRA HIGH PERFORMANCE LIQUID CHROMATOGRAPHY EQUIPMENT FOR TESTING RESIDUAL MONOMER LEVELS OF IOL SOFT ACRYLIC MATERIAL.

Current openFDA PMA Record#

Device: SENSAR 1-PIECE LENS MODEL AAB00
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S053
Decision date: 2014-11-15
Decision code: OK30
Date received: 2014-10-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE FROM MACHINED TO A MOLDED IOL EDGE BLOCKER, CHANGE IN CYCLE TIME FOR THE IOL TUMBLING PROCESS, ADDITION OF A COSMETIC INSPECTION FOLLOWINGSTERILIZATION, CHANGE IN TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF IOLS, ANDNEW ULTRA HIGH PERFORMANCE LIQUID CHROMATOGRAPHY EQUIPMENT FOR TESTING RESIDUAL MONOMER LEVELS OF IOL SOFT ACRYLIC MATERIAL.