DEVICE DETAILS
| NAME OF DEVICE | SOFT CONTACT LENS |
|---|---|
| ESTABLISHMENT NAME | MAXVUE VISION SDN BHD |
| ROLE OF ESTABLISHMENT | MANUFACTURER |
| REGISTRATION NO | GC172941046418 |
| BRAND NAME | PHANTASEE |
| MEDICAL DEVICE CATEGORY | MD 0105 - Non-active ophthalmologic devices |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | MAXVUE VISION SDN BHD'S SOFT CONTACT LENSES ARE HEMISPHERICAL SHELLS WITH MOULDED SPHERICAL BASE CURVES AND LATHE-CUT FRONT SURFACES. THE LENSES ARE FABRICATED FROM A NON-IONIC POLYMER. THE NON-IONIC LENS MATERIAL IS A HYDROPHILIC POLYMER OF 2-HYDROXYETHYL METHACRYLATE (2-HEMA) AND CROSS-LINKED WITH CROSSLINKING AGENT. THE LENSES ARE IMMERSED IN NORMAL BUFFERED SALINE SOLUTION. |
| DEVICE INTENDED PURPOSE | MAXVUE VISIONS SOFT CONTACT LENSES FOR DAILY WEAR ARE INDICATED FOR THE CORRECTIONS OF VISUAL ACUITY IN APHAKIC AND NOT APHAKIC PERSON WITH NON-DISEASED EYES WITH MYOPIA OR HYPEROPIA. THE LENS MAY BE WORN BY PERSONS WHO EXHIBIT REFRACTIVE ASTIGMATISM OF 0.50 DIOPTERS OR LESS WHERE THE ASTIGMATISM DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS IS ALSO USED TO ENHANCE OR ALTER THE APPARENT COLOUR OF THE EYE. EYE CARE PRACTITIONERS MAY PRESCRIBE THE ABOVE LENSES FOR FREQUENT/PLANNED REPLACEMENT WEAR, WITH CLEANING DISINFECTION AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR, THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTING SYSTEM. |
| VALIDITY DATE OF REGISTRATION | 02/07/2018 - 01/07/2023 |