510(k) K130331 ยท MVN Lens, Contact, (Disposable)
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
| Applicant | Sauflon Pharmaceuticals, Ltd., Twickenham, Middlesex, GB |
| Decision | Substantially Equivalent, Jul 26, 2013 |
| Received | Feb 11, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130331
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | CooperVision, Inc. Brand Name: Pearle Vision 1 day
Product Name: (somofilcon A) Contact Lens
Model/Catalog Number: Pearle Vision 1 day Open, Classified |
MVN | None listed |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power: -07.50 -0.75/060
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power -07.00 -1.75/170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power -07.00 -1.25/180
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. SPECSAVERS UMERE TORIC Power -07.00 -1.25/180
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC -DIAGNOSTIC
Power-07.00 -1.75/170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power -07.00 -1.75/170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. MEDIFLEX ELITE 1 DAY TORIC
Power -07.00 -1.75/170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. CLARITI 1 DAY TORIC Power -07.00 -1.25/010
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| May 19, 2021 | CooperVision Inc. SOFMED
BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170
Daily Disposable Contact Lens with UV blocker Terminated |
LPL | None listed |
| Feb 21, 2018 | CooperVision Inc. clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV b Terminated |
MVN | None listed |
| Feb 21, 2018 | CooperVision Inc. clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is Terminated |
MVN | None listed |
| Feb 21, 2018 | CooperVision Inc. 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indic Terminated |
MVN | None listed |
| Feb 21, 2018 | CooperVision Inc. 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses
The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indic Terminated |
MVN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.