Data / Medical devices / United States / Johnson & Johnson Surgical Vision, Inc.
Johnson & Johnson Surgical Vision, Inc.: FDA-registered device maker in Irvine, CA, United States, 35 510(k) clearances and 11 PMA approvals
Johnson & Johnson Surgical Vision, Inc. is registered with the FDA (registration 3012236936) in Irvine, CA, United States. It lists 20 device types. The FDA files 35 510(k) clearances and 11 PMA approvals under its listings, the newest dated March 12, 2021. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012236936
- Address
- 31 Technology Drive Suite 200, Irvine, CA, United States, 92618
- Owner or operator
- Johnson & Johnson Surgical Vision, Inc. (10053607)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 22, 2016
- Registered through
- 2026
- Brand names listed
- AID, SURGICAL, VISCOELASTIC, Accessories, soft lens products, Cannula, Ophthalmic, Case, Contact Lens, Device, irrigation, ocular surgery, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES, Excimer laser system, FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2021 | K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | HQC | Substantially Equivalent | Johnson & Johnson Surgical Vision, Inc. | accessdata.fda.gov |
| September 13, 2019 | K191949 | UNFOLDER Vitan Inserter | MSS | Substantially Equivalent | Johnson & Johnson Surgical Vision, Inc. | accessdata.fda.gov |
| April 27, 2016 | K160236 | Dual Pump Pack | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| October 19, 2015 | K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| September 2, 2015 | K151783 | COMPACT INTUITIV Multiple-Use Pack | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| May 6, 2015 | K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series | MSS | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| September 11, 2014 | K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| February 27, 2014 | K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| October 15, 2012 | K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| August 28, 2012 | K121091 | CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| December 21, 2011 | K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| December 21, 2011 | K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| November 7, 2011 | K111882 | LAMINAR FLOW PHACO TIPS | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| September 27, 2011 | K111697 | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| September 15, 2010 | K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION | LPN | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| October 23, 2008 | K081382 | DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 | KYB | Substantially Equivalent | Duckworth & Kent, Ltd. | accessdata.fda.gov |
| October 8, 2008 | K081681 | VITRECTOMY CUTTER AND ACCESSORIES | MLZ | Substantially Equivalent | Advanced Medical Optics, Inc. | accessdata.fda.gov |
| October 2, 2008 | K081545 | ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 | MSS | Substantially Equivalent | Advanced Medical Optics, Inc. | accessdata.fda.gov |
| April 25, 2008 | K073404 | IFS LASER SYSTEM | GEX | Substantially Equivalent | Intra Lase Corp. | accessdata.fda.gov |
| August 16, 2006 | K060372 | INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 | GEX | Substantially Equivalent | Intra Lase Corp. | accessdata.fda.gov |
| April 7, 2006 | K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM | HQC | Substantially Equivalent | Advanced Medical Optics, Inc. | accessdata.fda.gov |
| August 2, 2002 | K012105 | POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM | KCT | Substantially Equivalent | Symmetry Medical, Inc. | accessdata.fda.gov |
| February 20, 2002 | K014202 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | LPN | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| February 13, 2001 | K003638 | MOJAVE CATARACT EXTRACTION SYSTEM | HQC | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| December 18, 1998 | K984383 | ULTRACARE NEUTRALIZING TABLETS | LPN | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| May 19, 1998 | K981116 | SOVEREIGN CATARACT EXTRACTION SYSTEM | KYG | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| February 18, 1997 | K955455 | BAERVELT PARS PLANA GLAUCOMA IMPLANT | KYF | Substantially Equivalent | Pharmacia Iovision, Inc. | accessdata.fda.gov |
| June 17, 1996 | K961242 | AMO PHACOFLEX II INTERSECTION SYSTEM | KYB | Substantially Equivalent | Allergan, Inc. | accessdata.fda.gov |
| June 15, 1995 | K951462 | AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM | HQC | Substantially Equivalent | Allergan Medical Optics | accessdata.fda.gov |
| October 13, 1994 | K943672 | PHACO NEEDLES AND TIPS | HQC | Substantially Equivalent | Microsurgical Technology, Inc. | accessdata.fda.gov |
| February 11, 1991 | K905129 | BAERVELDT GLAUCOMA IMPLANT | KYF | Substantially Equivalent | Wright Medical Corp. | accessdata.fda.gov |
| December 19, 1985 | K844373 | O.M.S. ULTRA-PHACO | HQC | Substantially Equivalent | Optical Micro Systems, Inc. | accessdata.fda.gov |
| May 22, 1984 | K840695 | PHACOEMULSIFICATION KITS | HQC | Substantially Equivalent | Innovative Surgical Products, Inc. | accessdata.fda.gov |
| June 2, 1983 | K831236 | BIPOLAR CARD | GEI | Substantially Equivalent | New England Surgical Instrument Corp. | accessdata.fda.gov |
| October 5, 1976 | K760684 | VISC X-VITREOUS ASPIRATING & CUT. INSTR | HKP | Substantially Equivalent | Varian Assoc., Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 2, 2012 | P110007 | HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE) | LZP | 15 | January 15, 2025 | accessdata.fda.gov |
| January 16, 2009 | P080010 | TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | MFK | 29 | October 19, 2026 | accessdata.fda.gov |
| April 5, 2001 | P990080 | CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A | HQL | 61 | October 19, 2026 | accessdata.fda.gov |
| February 3, 2000 | P980040 | SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | HQL | 174 | October 19, 2026 | accessdata.fda.gov |
| September 5, 1997 | P960028 | AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS | MFK | 36 | October 27, 2017 | accessdata.fda.gov |
| March 27, 1996 | P930016 | VISX EXCIMER LASER SYSTEM MODELS B AND C | LZS | 62 | August 9, 2024 | accessdata.fda.gov |
| October 31, 1989 | P880081 | UV ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES | HQL | 39 | September 27, 2024 | accessdata.fda.gov |
| August 27, 1987 | P860061 | ULTRAZYME PROTEIN CLEANER | LPN | 10 | October 11, 1995 | accessdata.fda.gov |
| May 8, 1987 | P850088 | OXYSEPT SYSTEM | LPN | 31 | July 3, 1997 | accessdata.fda.gov |
| January 14, 1983 | P810031 | HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES | LZP | 75 | July 28, 2026 | accessdata.fda.gov |
| November 2, 1979 | N18020 | ALLERGAN PRESERVED SALINE SOLUTION | LPN | 36 | April 12, 1996 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | 99496 | Class II | Ongoing | 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) | Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is encountered during insertion, withdraw cannula and reassess the insertion conditions (i.e. insertion angle, incision size, etc.) before proceeding because forcing the cannula may cause corneal abrasion, iris trauma | accessdata.fda.gov |
| March 14, 2024 | 94231 | Class II | Ongoing | Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsificat | Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms. | accessdata.fda.gov |
| December 12, 2023 | 93523 | Class II | Ongoing | TECNIS Toric II OptiBlue IOL Models ZCW | Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM) and toric cylinder axis marks. | accessdata.fda.gov |
| July 6, 2023 | 92666 | Class II | Ongoing | TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only | Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks. | accessdata.fda.gov |
| May 30, 2023 | 92539 | Class II | Ongoing | VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF) | Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which cou | accessdata.fda.gov |
| December 7, 2022 | 91290 | Class II | Ongoing | Veritas Advanced Infusion Packs, REF: VRT-AI | Weld protrusion/physical gap between the housing and phaco pack cover, may exceed design specification, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient c | accessdata.fda.gov |
| September 7, 2022 | 90887 | Class II | Ongoing | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapping (stimulation and recording) and, in conjunction with an RF generator, for cardia | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation ma | accessdata.fda.gov |
| September 1, 2022 | 90847 | Class II | Ongoing | Veritas Advanced Infusion Packs. Used in ophthalmic procedures. | As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue. | accessdata.fda.gov |
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Updated August 31, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.