PMA P940013S006

Device: PRECISION(TM) UV (VASURFILCON)
Applicant: Alcon Laboratories, Inc.
PMA number: P940013
Supplement: S006
Product code: LPM
Decision date: 1999-01-07
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for modifications to the labeling, including an additional indications statement, "Precision UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye"; and modified Note and Warning as stated below: "Warning: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed."

Current openFDA PMA Record

Device: PRECISION(TM) UV (VASURFILCON)
Applicant: Alcon Laboratories, Inc.
PMA number: P940013
Supplement: S006
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1999-01-07
Decision code: APPR
Date received: 1998-08-26
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the labeling, including an additional indications statement, "Precision UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye"; and modified Note and Warning as stated below: "Warning: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed."