PMA P990072
- Device
- W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
- Applicant
- Westcon Contact Lens Co., Inc.
- PMA number
- P990072
- Product code
- LPM
- Decision date
- 2000-08-22
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- APPROVAL FOR THE HORIZON 55 EW AND HORIZON 55 EW WESTINT (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND VISIBILITY TINT). THESE DEVICES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVEL FOR CLEANING, RINSING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON DISEASED EYES THAT ARE MYOPIC OR HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 1.50 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P990072B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
- Applicant
- Westcon Contact Lens Co., Inc.
- PMA number
- P990072
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2000-08-22
- Decision code
- APWD
- Date received
- 1999-11-16
- Approval order statement
- APPROVAL FOR THE HORIZON 55 EW AND HORIZON 55 EW WESTINT (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND VISIBILITY TINT). THESE DEVICES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVEL FOR CLEANING, RINSING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON DISEASED EYES THAT ARE MYOPIC OR HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 1.50 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.