PMA P090022S029

Device: LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S029
Product code: HQL
Decision date: 2016-09-28
Generic name: intraocular lens
Approval order statement: Addition of a dishwasher for use in the removal of microbial contamination from packaging and device components used in the manufacture of the LENSTEC Softec Posterior Chamber IOLs.

Current openFDA PMA Record#

Device: LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Lenstec, Inc.
PMA number: P090022
Supplement: S029
Product code: HQL
Generic name: intraocular lens
Decision date: 2016-09-28
Decision code: OK30
Date received: 2016-08-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a dishwasher for use in the removal of microbial contamination from packaging and device components used in the manufacture of the LENSTEC Softec Posterior Chamber IOLs.