Johnson & Johnson Surgical Vision, Inc.
FDA adverse event reports naming Johnson & Johnson Surgical Vision, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: JOHNSON & JOHNSON SURGICAL VISION, INC..
- Total reports
- 9,991
- Deaths
- 1
- Injuries
- 6,249
- Malfunctions
- 3,738
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Intraocular LensHQL3,400
- Keratome, Ac-PoweredHNO2,170
- Extended Depth Of Focus Intraocular LensPOE1,570
- Unit, PhacofragmentationHQC813
- Lens, Multifocal IntraocularMFK654
- Lens, Guide, IntraocularKYB393
- Ophthalmic Femtosecond LaserOOE267
- Aid, Surgical, ViscoelasticLZP245
- Implant, Eye ValveKYF152
- Excimer Laser SystemLZS150
Recent recalls
- 2024-05-02Open, ClassifiedProcess control
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 phacoemulsification tip, allowing the solution to enter the eye during ocular surgery.
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.
- 2024-01-16Open, ClassifiedUnder Investigation by firm
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.
- 2023-08-03Open, ClassifiedUnder Investigation by firm
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.
- 2023-08-03Open, ClassifiedUnder Investigation by firm
TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
- 2023-07-28Open, ClassifiedProcess control
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 could result in transient corneal edema.
- 2023-01-20Open, ClassifiedProcess control
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 corneal edema.
- 2023-01-20Open, ClassifiedProcess control
FUSION Dual Pump Packs, REF: OPO73
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 corneal edema.
- 2023-01-20Open, ClassifiedProcess control
Single-Use Packs, REF: OPO80
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 corneal edema.
- 2022-11-02Open, ClassifiedProcess control
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 cardiac ablation.
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 may have thrombogenic/toxic effect.
- 2022-10-12Open, ClassifiedUnder Investigation by firm
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.
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