PMA P010019S087
- Device
- FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P010019
- Supplement
- S087
- Product code
- LPM
- Decision date
- 2026-05-29
- Classification
- Ophthalmic
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- revise the quality control testing for finished product batch release of lotrafilcon A and B contact lens products
Current openFDA PMA Record#
- Device
- FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P010019
- Supplement
- S087
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2026-05-29
- Decision code
- OK30
- Date received
- 2026-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- revise the quality control testing for finished product batch release of lotrafilcon A and B contact lens products