Precision(Tm) UV (Vasurfilcon)

FDA premarket approval P940013 · Lenses, soft contact, extended wear

PMA numberP940013

Approval

Applicant
Alcon Laboratories, Inc.
Received
May 6, 1994
Decision date
September 30, 1994 (APWD)
Supplements
7, latest April 13, 2010
Product code
LPM – Lenses, Soft Contact, Extended Wear

Official FDA PMA record

Approval order statement

FOR THE PRECISION (IV' (VASURFILCON A) HYDROPHILIC CONTACTLENS FOR EXTENDED WEAR. THIS DEVICE IS INDICATED FOR NON-APHAKIC DAILY OREXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING, RINSING, ANDDISINFECTING, AS RECOMMENDED BY THE EYE CARE PRACTITIONER. CANDIDATES TO USETHE PRECISION UV'" HYDROPHILIC CONTACT LENS INCLUDE PERSONS WHO ARE NEARSIGHTED(MYOPIC) AND FARSIGHTED (HYPEROPIC) AND WHO MAY HAVE ASTIGMATISM OF 2.0DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.