Unicoeye; Barbie (Polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
BARBIE is a soft daily wear contact lens for correcting myopia in people with nondiseased eyes, including people with or without a natural lens. It may be used with refractive astigmatism…
BARBIE is a soft daily wear contact lens for correcting myopia in people with nondiseased eyes, including people with or without a natural lens. It may be used with refractive astigmatism of 0.50 diopters or less when that astigmatism does not interfere with visual acuity.
The hydrated lens contains 62% polymacon and 38% water by weight. Its cosmetic tint forms an annular pattern around a clear optical zone and is sandwiched between two layers of lens material to alter the apparent eye color.
Replacement and Care
An eye care practitioner determines the replacement schedule. Frequent or planned replacement wear requires cleaning and disinfection; when prescribed for daily disposable wear, each lens is discarded after one use. The lenses are supplied sterile in saline-filled blister packs.
5manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Hong Kong (2), Guangdong (2), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Objectt Optik Company Limited | Hong Kong | Hong Kong | Contract manufacturer | 8 |
| Bloom MAX Limited | Central | Hong Kong | Manufacturer | 3 |
| Hunan Haipuming Technology Co., Ltd. | Shaoyang | Hunan | Manufacturer | 2 |
| Shenzhen Dashicheng Optical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
| Shenzhen Lensgoo Vision Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 1 |
Record
| Listed by | Shenzhen Dashicheng Optical Technology Co., Ltd., China |
|---|---|
| FDA product code | LPL |
| Device type | Lenses, Soft Contact, Daily Wear |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5925 |
| Establishment | Manufacturer |
| 510(k) | K220143 |
| Record published | 2023-05-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BARBIE | In distribution | ||
| BARBIE | 2 | In distribution | |
| BARBIE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Miru 1day Menicon Flat Pack TC CP30 | Menicon Co., Ltd. | 693 |
| Miru 1day Menicon Flat Pack TC CP90 | Menicon Co., Ltd. | 693 |
| 1-Day Flat Pack TC CP90 | Menicon Co., Ltd. | 693 |
| Miru 1day Menicon Flat Pack TC Trial6 | Menicon Co., Ltd. | 693 |
| coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | 480 |
| COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | 444 |
| mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | 288 |
| ZonedIn Contact Lenses | Zonedin Vision LLC | 201 |
| Loox | Camden Passage | 199 |
| ArtMost SoftOK Daily Wear Soft Contact Lens | Seinoh Optical Co., Ltd. | 192 |
| Myeyebb, HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | 145 |
| Comfort Colors | NEW York Optical Intl., Inc. | 144 |
Showing 12 of 119. All products under Lenses, Soft Contact, Daily Wear
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220143 | 2022-09-08 |
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 |
|---|---|---|---|
| N17752 | 1994-11-09 | HYDROCURVE | Ciba Vision Gmbh |
| P890049 | 1994-07-06 | FINISHED METHAFILCON A CONTACT LENSES | Lombart Lenses, Ltd. |
| P910029 | 1993-11-23 | \YDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES | Les Laboratories Blonchard |
| P880049 | 1992-07-23 | EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES | Epcon Laboratories |
| P830006 | 1992-04-15 | SOFTACT II (POLYMACON) | Premier Contact Lens |
| P880102 | 1992-03-05 | LOMBART (POLYMACON) SOFT CONTACT LENSES | Lombart Lenses, Ltd. |
| P880101 | 1991-12-03 | AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE | Unilens Corp., USA |
| P900058 | 1991-08-29 | FLEXLENS (HEFILCON A) SOFT CONTACT LENSES | Westcon Contact Lens Co., Inc. |
| P900065 | 1991-08-29 | TECHNICON-38 (POLYMACON) HYDROPHYLIC LENSES | Westcon Contact Lens Co., Inc. |
| P850002 | 1991-06-12 | ALGES(TM) (HEFILCON A) CONTACT LENS | Unilens Corp., USA |
| P840006 | 1991-04-24 | SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS | Salvatori Ophthalmics Mfg. Corp. |
| P890031 | 1991-03-06 | OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI | Ocular Technologies, Inc. |
| P860040 | 1990-11-21 | SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES | Wavetouch Technologies, LLC |
| P850039 | 1990-09-11 | B&L 58(TM) (ETAFILCONA) CONTACT LENS | Bausch & Lomb Incorporated |
| P890053 | 1990-09-11 | O.P.R. -55 SOFT CONTACT LENS | N & N Contact Lens Co., Ltd. |
| P890029 | 1990-03-06 | EXCELENS (ATLAFILCON A) CONTACT LENS | Ciba Vision Gmbh |
| P810005 | 1990-01-31 | WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS | Ciba Vision Care |
| P870019 | 1989-12-11 | ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS | Hanita Contact Lens Laboratory |
| P820059 | 1989-09-18 | PERMATINT(R) | Wesley Jessen Corp. |
| P850079 | 1989-09-06 | HYDRASOFT (METHAFILCON A) CONTACT LENS | CooperVision, Inc. |
| P870079 | 1989-06-02 | TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS | United Contact Lens Inc |
| P860009 | 1989-05-09 | IGEL 67 CONTACT LENS | Contamac Ltd. |
| P800031 | 1989-05-05 | (MAFILCON) SOFT CONTACT LENSES | N&N Menicon, Inc. |
| P850078 | 1989-03-14 | KONTUR SOFT (METHAFILCON A) LENS | Kontur Kontact Lens Co., Inc. |
| P830077 | 1989-02-21 | METRO 55 (METHAFILCON A) | Metrosoft, Inc. |
| N17554 | 1989-01-12 | SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS | Ciba Vision Care |
| P820026 | 1988-11-10 | METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT | Metrosoft, Inc. |
| P820051 | 1988-09-19 | STERILIZED FINISHED OCUFILCON B LENSES | Ocu-Ease Optical Products, Inc. |
| P830012 | 1988-08-29 | SOFTICS(TM) (POLYMACON) | Ideal Optics, Inc. |
| P840071 | 1987-10-27 | TINTED TETRAFILCON A CONTACT LENSES | Ciba Vision Gmbh |
| P830003 | 1987-09-28 | SOFTVIEW SPHERICAL & TORIC CONTACT LENS | Optical Plastic Research |
| N17987 | 1987-06-16 | SOFT CONTACT LENS | Ciba Vision Gmbh |
| P820005 | 1987-02-20 | (POLYMACON) CONTACT LENSES | Salvatori Ophthalmics Mfg. Corp. |
| P800020 | 1985-11-05 | SILSOFT (ELASTOFILCON A ) CONTACT LENS | Dow Corning Corp. Healthcare Industries Materials |
| N17793 | 1985-09-30 | SOFTSITE (HEFILCON A) CONTACT LENS | Unilens Corp., USA |
| N17734 | 1985-08-15 | ACCUSEPT DISINFECTING UNIT | Strieter Laboratories, Inc. |
| N17375 | 1985-07-22 | SOFTCON BANDAGE LENS | Ciba Vision Care |
| N17976 | 1984-12-10 | FLEXLENS | Paragon Vision Sciences, Inc. |
| P810050 | 1984-11-20 | OPTECH FRE-FLEX SOFT CONTACT LENS | Optech, Inc. |
| N17855 | 1984-03-29 | TRESOFT SOFT CONTACT LENSE | Ciba Vision Care |
| P800054 | 1984-03-12 | SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR | Dow Corning Corp. Healthcare Industries Materials |
| P820078 | 1984-01-30 | AL-47 SOFT CONTACT LENS | Alden Optical Labs., Inc. |
| P820017 | 1983-04-28 | HYDRACON(R) CONTACT LENSES | Hydracon |
| P800011 | 1982-11-23 | WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES | Ciba Vision Gmbh |
| P810057 | 1982-10-08 | COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS | CooperVision, Inc. |
| P800070 | 1982-03-01 | SOFTACT(TM) (DELTAFILCON A) | Premier Contact Lens |
| P800013 | 1982-02-05 | METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES | Metrosoft, Inc. |
| N18146 | 1981-11-27 | SOF FORM (DELTAFILCON A) | Unilens Corp., USA |
| N18180 | 1981-05-11 | CUSTOMFLEX (DELTAFILCON A) HYDROPHILIC CONTACT LEN | Wesley Jessen Corp. |
| N17852 | 1980-10-17 | DURASOFT CONTACT LENS | Wesley Jessen Corp. |
| P780013 | 1980-06-19 | TRI POL 43 CONTACT LENS | Gbf Contact Lenses, Inc. |
| N18018 | 1980-05-21 | ARMSOF SOFT CONTACT LENSE | Lombart Optical of Virginia, Ltd. |
| P790015 | 1980-04-25 | SOFTICS (DELTAFILCON A) LENS | Advanced Soft Optics, Inc. |
| N17722 | 1980-03-14 | GELFLEX(R) (DIMEFILCON A) CONTACT LENS | Dow Corning Ophthalmics, Inc. |
| N18001 | 1979-08-08 | MINITHEERM | Ciba Vision Care |
| N18162 | 1979-06-07 | TRI POL | Aquarius Soft Lens, Inc. |
| N17951 | 1979-03-23 | TRI POL 43 CONTACT LENS | Applied Optics, Inc. |
| N17676 | 1979-02-26 | NATUREVUE CONTACT LENSE | Bausch & Lomb Incorporated |
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.