Boston ES
Catalogue number enflufocon A, listed by Bausch & Lomb Incorporated, United States, under Lens, Contact (Other Material) - Daily. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
8510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Registered in Tianjin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tianjin Mastervision Technology Co., Ltd. | Wuqing District | Tianjin | Manufacturer | 2 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HQD |
| Device type | Lens, Contact (Other Material) – Daily |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5916 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-10-24 |
| Record revised | 2026-03-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| enflufocon A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BostonSight Scleral | The Boston Foundation For Sight, Inc. | 17 |
| BostonSight Prose | The Boston Foundation For Sight, Inc. | 17 |
| Acuity | Acuity Polymers Inc. | 6 |
| Custom Stable | Valley Contax, Inc | 4 |
| EyeSpace Bespoke | Tianjin Mastervision Technology Co., Ltd. | 2 |
| EyeSpace Scleral | Tianjin Mastervision Technology Co., Ltd. | 2 |
| Optimum HR 1.53 | Contamac Ltd. | 1 |
| Boston IV | Bausch & Lomb Incorporated | 1 |
| Optimum Extreme | Contamac Ltd. | 1 |
| Oxfore100 | Paragon Vision Sciences, Inc. | 1 |
| Optimum Classic | Contamac Ltd. | 1 |
| SA-18 | Lagado Corporation, THE | 1 |
Showing 12 of 54. All products under Lens, Contact (Other Material) – Daily
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K183167 | 2019-02-12 |
| K171404 | 2017-07-17 |
| K073184 | 2008-02-21 |
| K071266 | 2007-08-15 |
| K071043 | 2007-08-02 |
| K053124 | 2006-01-30 |
| K022128 | 2002-08-22 |
| K013762 | 2002-04-03 |
Recalls
2 of these are Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-07-03 | Class III | Process control | Vials labeled for the prescriptions contained incorrect lenses | 4 vials | 2020-02-28 |
| 2018-07-03 | Class III | Process control | Vials labeled for the prescriptions contained incorrect lenses | 36 vials | 2020-02-28 |
| 2010-04-20 | Not classified | Process control | The amount of D&C #6 Dye added to the formulation exceeded specified amounts. | 2575 buttons | 2016-04-27 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P860022 | 1998-03-31 | IPAFLUOROFOCON A AND B | Bausch & Lomb Incorporated |
| P880024 | 1994-03-04 | N-18 (KOLFOCON A),N-32 (KOLFOCON B) LENS MATERIAL | The Lagado Corp. |
| P920045 | 1994-02-24 | OP-3 (TM) RGP CONTACT LENS | Stellar Contact Lens, Inc. |
| P890072 | 1994-01-07 | ALBERTA LENS S (SULFOCON A) RGP CONTACT LENS | Progressive Chemical Research, Ltd. |
| P820056 | 1994-01-04 | OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS | Paragon Vision Sciences, Inc. |
| P880035 | 1993-05-19 | VISTACRYL 18(KOLFOCON A) 32(KOFOCON B) RGP LENSES | Vista Optics, Ltd. |
| P890044 | 1993-02-09 | TRANSAIRE(TM) RIGID GAS PERMEABLE CONTACT LENSES | Rand Scientific Corp. |
| P900001 | 1992-12-04 | RIGID GAS PERMEABLE CONTACT LENSES | THE Lifestyle Co., Inc. |
| P890058 | 1991-07-19 | NOVALENS (ROSILFOCON A) | Ocutec Corporation, Inc. |
| P850038 | 1991-02-05 | PARAPERM E.W. (PASIFOCON A) RGP CONTACT LENS | Paragon Optical Co. |
| P880001 | 1990-12-12 | FLUOREX(TM) FFLUSILFOCON) 700,500,300 RGP LENS | G.T. Laboratories, Inc. |
| P890046 | 1990-09-10 | O-PERM F60 RGP CONTACT LENS | Optical Polymer Research, Inc. |
| P880041 | 1990-05-08 | MODEL UV44B INTRAOCULAR LENS | Abbott Medical Optics, Inc. |
| P840055 | 1990-03-15 | RIGID GAS PERMEABLE CONTACT LENSES | THE Lifestyle Co., Inc. |
| P840050 | 1986-12-31 | OCUSIL(TM) CONTACT LENS | O.S.I. Corp. |
| P820074 | 1984-06-25 | OPUS – III CONTACT LENSES | Wesley Jessen Corp. |
| P820062 | 1984-03-16 | PARAPERM O2 CLEAR & BLUE LENS | Salvatori Ophthalmics Mfg. Corp. |
| P790010 | 1982-05-28 | DANKER SILICONE LENS (DIMEFOCON-A) | Ciba Vision Gmbh |
| N17878 | 1981-02-24 | MESO(CELLULOSE ACETATE BUTYRATE) HARD CONTACT LENS | Danker Laboratories, Inc. |
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.