Panels › Ophthalmic › Product code LZP · Class 3
Aid, Surgical, Viscoelastic
Regulation 886.4275
0510(k)s in 12 months (0 all time)
1recalls in 12 months (25 all time)
0recalls that name a 510(k)
Top companies in LZP
| Company | 510(k)s | Recalls |
|---|---|---|
| Anika Therapeutics | 0 | 12 |
| Abbott Medical Optics Inc (AMO) | 0 | 7 |
| Johnson & Johnson Surgical Vision Inc | 0 | 2 |
| Advanced Medical Optics, Inc. | 0 | 1 |
| Becton Dickinson and Company | 0 | 1 |
| C.L.R. Medicals International, Inc. | 0 | 1 |
| Staar Surgical Co Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2026 | Johnson & Johnson Surgical Vision, Inc. HEALON EndoCoat PRO, REF: 10300012 (US/CAN)
HEALON DUET PRO II, REF: 10300016 (US/CAN)
HEALON EndoCoat PRO, REF: 10301012 (EU);
HEALON DUET PRO II, REF: 10301016 (EU) Open, Classified |
LZP | None listed |
| Jan 27, 2020 | Johnson & Johnson Surgical Vision Inc Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon V, Part No. 10290045 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon Pro, Part No. 10270012 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon 5 Pro, Part No. 10270015 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 Terminated |
LZP | None listed |
| Apr 1, 2017 | Abbott Medical Optics Inc. (AMO) Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701 Terminated |
LZP | None listed |
| Dec 12, 2014 | Abbott Medical Optics Inc (AMO) Abbott Healon EndoCoat Ophthalmic Viscosurgical Device
3% sodium hyaluronate
0.85 mL 30 mg/mL
Sterile A Solution
Sterile EO Packaging and Cannula
Product of USA
Abbott Healon Duet Dual Pack
0.55 ml O Terminated |
LZP | None listed |
| Dec 20, 2013 | C.L.R. Medicals International, Inc. Viscocel and Viscocel Plus.
These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain ante Terminated |
LZP | None listed |
| Dec 16, 2010 | Becton Dickinson and Company Beaver-Visitec International (Beaver-Visitec) BD 1% OVD Sodium Hyaluronate, 10 mg/ml 1.0 mL. Sterile. Rx
For Intraocular Use
REF 585304
Use as a surgical aid to protect corneal endothelium during cat Terminated |
LZP | None listed |
| Dec 10, 2008 | Advanced Medical Optics, Inc. AMO Healon D Ophthalmic Viscosurgical Device, Product Code: 10204011, Lot Number: UD30654, 30 mg/mL fill size Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. Amvisc Plus Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY
Product Number: 60081 Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. Amvisc Plus Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY
Product Number: 60051 Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. Amvisc Sodium Hyaluronate 0.8 mL. Bausch & Lomb, Inc., Rochester, NY
Product Numbr: 59081 Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. Amvisc Sodium Hyaluronate 0.5 mL. Bausch & Lomb, Inc., Rochester, NY
Product Number: 59051 Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. ShellGell Sodium Hyaluronate 0.8mL Syringe, 12 mg/mL. Sterile. Rx. For intraocular use. Product Number: 1000 Distributed by Cytosol Opthalmics, Inc., Lenick, NC Terminated |
LZP | None listed |
| Aug 23, 2005 | Anika Therapeutics, Inc. Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use. P/N490-001 Distributed by: STAAR Surgical Inc., Monrovia CA Terminated |
LZP | None listed |
| Aug 6, 2005 | Staar Surgical Co Inc Staarvisic II
Sodium Hyaluronate, 0.8 mL Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics Amvisc Intraocular Injection Sodium hyaluronate 12 mg/ml
For European Distribution
Manufactured for Bausch & Lomb Surgical,Irvine,CA and Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics Hialuronato Sodico Sodium Hyaluronate 12 mg/mL 1X0.8 mL Sterile. RX. For Intraocular use.
Product Number: 014-180A Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics DomiVisc Sodium Hyaluronate 0.8 mL 12 mg.mL Syringe. Sterile.RX. For intraocular use
Product Numbner; P012-180A
Manufactured for Bausch & Lomb Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics Amvisc Sodium Hyaluronate 0.8 mL 12 mg/mL Syringe. Sterile. RX. For intraocular use.
Product Number: 780A
Manufactured for Bausch & Lomb Surgical Inc., Irvin, CA Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics Staarvisc II Sodium Hyaluronate 0.8 mL 12mg/mL Syringe. Sterile. Rx. For intraocular use.
P/N490-001
Distributed by: STAAR Surgical Inc., Monrovia CA Terminated |
LZP | None listed |
| Nov 13, 2003 | Anika Therapeutics ShellGell Sodium Hyaluronate 0.8mL Syringe,
12 mg/mL. Sterile. Rx. For intraocular use.
Product Number: 1000
Distributed by Cytosol Opthalmics, Inc., Lenick, NC Terminated |
LZP | None listed |
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