ScleralFil
Contact Lens Sterile Saline Solution
1manufacturer
1catalogue number
4510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| AMO (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 2 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | MRC |
| Device type | Products, Contact Lens Care, Rigid Gas Permeable |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5918 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2023-07-05 |
| Record revised | 2024-05-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TBD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bausch + Lomb | Bausch & Lomb Incorporated | 15 |
| Menicon Unique pH Multi-Purpose Solution | Menicon America, Inc. | 3 |
| Equate | Wal Mart Stores, Inc | 3 |
| Menicon Progent Protein Remover | Menicon America, Inc. | 2 |
| Nutrifill | Contamac Solutions, Inc. | 2 |
| Tangible Clean Sample Bottle | Tangible Science Inc | 2 |
| Tangible Clean | Tangible Science Inc | 2 |
| cleadew GP hydra one | Ophtecs Corporation | 2 |
| PuriLens Plus Preservative Free Saline | Lifestyle Co Inc, THE | 2 |
| VibrantVue | DRY EYE Innovations, LLC | 2 |
| Meijer | Meijer, Inc. | 2 |
| up & up rigid gas permeable contact lens conditioning solution | Target Health, Inc. | 1 |
Showing 12 of 18. All products under Products, Contact Lens Care, Rigid Gas Permeable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200416 | 2020-09-23 |
| K181627 | 2018-08-10 |
| K173089 | 2017-11-27 |
| K024289 | 2003-05-02 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-10-30 | Not classified | Other | The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors. | 159,672 bottles | 2012-08-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.