Lens, Contact, Orthokeratology, Overnight
Basic Information
- Device Name
- Lens, Contact, Orthokeratology, Overnight
- Trade Name
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT
- PMA Number
- P010062
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- NUU
- Generic Name
- Lens, contact, orthokeratology, overnight
- Regulation Number
- 886.5916
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 2, 2004
- Date Received
- July 6, 2004
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE PROTOCOL TO BE USED TO ADD CONTACT LENS FINISHING LABORATORIES TO MANUFACTURE THE SUBJECT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT AND IS INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING ASTIGMATISM UP TO 1.5 DIOPTERS. THE LENSES MAY ONLY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM. NOTE: TO MAINTAIN THE ORTHOKERATOLOGY EFFECT OF MYOPIA REDUCTION, OVERNIGHT LENS WEAR MUST BE CONTINUED ON A PRESCRIBED SCHEDULE. FAILURE TO DO SO CAN AFFECT DAILY ACTIVITIES (E.G., NIGHT DRIVING), VISUAL FLUCTUATIONS AND CHANGES IN INTENDED CORRECTION.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUU | Lens, Contact, Orthokeratology, Overnight | FDA class 3 | Ophthalmic |