HSA · registration DE0508325Alcon TOTAL30™ for ASTIGMATISM
- Registration number
- DE0508325
- Model name
- Total 30 for Astigmatism (-10.00 D to 0.00 D, +0.25 to +8.00 D), Base Curve: 8.6mm; Diameter: 14.5mm; Cylinder: -0.75 D, -1.25 D, -1.75 D, -2.25 D, -2.75 D; Axis: 10° - 180° (10° steps); Pack of 1, 3, 6
- Model identifier
- Total 30 for Astigmatism
- Registration date
- July 25, 2023
- Risk class
- Class B
- Product owner
- Alcon Laboratories, Inc.
- Registrant / registration holder
- ALCON PTE LTD
TOTAL30™ for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia or hyperopia, with astigmatism) in persons with non- diseased eyes. The lenses are intended for daily wear (less than 24 hours while awake), with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eye care professional. Lenses should be discarded and replaced with a new pair each month, or more often, if recommended by the eye care professional.
- Product owner address
- 6201 South Freeway, Fort Worth, Texas 76134-2099, United States
- Registrant address
- 1 FUSIONOPOLIS WALK, #08-02, SOLARIS, Singapore 138628
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.