PMA P980040S121

Device: One-Piece IOLs with Daisy-Wheel packaging configuration, One-Piece IOLs with TENIC iTEC Preloaded Delivery System, One-P
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S121
Product code: HQL
Decision date: 2020-09-23
Generic name: intraocular lens
Approval order statement: Conducting the flat time test prior to sterilization as opposed to post sterilization as an in-process control for IOLs, within 24 hours of samples being delivered to the flat test area at AMO Puerto Rico site.

Current openFDA PMA Record#

Device: One-Piece IOLs with Daisy-Wheel packaging configuration, One-Piece IOLs with TENIC iTEC Preloaded Delivery System, One-P
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S121
Product code: HQL
Generic name: intraocular lens
Decision date: 2020-09-23
Decision code: OK30
Date received: 2020-08-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Conducting the flat time test prior to sterilization as opposed to post sterilization as an in-process control for IOLs, within 24 hours of samples being delivered to the flat test area at AMO Puerto Rico site.