PMA P010019S049
- Device
- FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P010019
- Supplement
- S049
- Product code
- LPM
- Decision date
- 2016-03-30
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- Moving the 'lens rinsing' step from after the 100% wet lens QA inspection to before the inspection.
Current openFDA PMA Record#
- Device
- FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P010019
- Supplement
- S049
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2016-03-30
- Decision code
- OK30
- Date received
- 2016-03-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Moving the 'lens rinsing' step from after the 100% wet lens QA inspection to before the inspection.