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Johnson & Johnson Surgical Vision Recalls
17 recalls on record · October 10, 2018 to May 8, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 8, 2024Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The ir
Hazard: 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.
January 24, 2024Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Toric II OptiBlue IOL Models ZCW
Hazard: 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.
August 9, 2023Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Hazard: Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
August 9, 2023Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Hazard: Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
August 9, 2023Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)
Hazard: 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.
February 1, 2023Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls Single-Use Packs, REF: OPO80
Hazard: 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.
February 1, 2023Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls FUSION Dual Pump Packs, REF: OPO73
Hazard: 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.
February 1, 2023Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls Veritas Advanced Infusion Packs, REF: VRT-AI
Hazard: 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.
November 9, 2022Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrop
Hazard: 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.
October 19, 2022Medical DevicesFDA
Johnson & Johnson Surgical Vision, Inc. recalls Veritas Advanced Infusion Packs. Used in ophthalmic procedures.
Hazard: As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.
May 11, 2022Medical DevicesFDA
Johnson & Johnson Surgical Vision Inc recalls TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Hazard: Potential breach in the sterility barrier for tray ring covers.
October 13, 2021Medical DevicesFDA
Johnson & Johnson Surgical Vision Inc recalls TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simpli
Hazard: Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
March 10, 2021Medical DevicesFDA
Johnson & Johnson Surgical Vision Inc recalls TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsula
Hazard: Due to the release of nonconforming Intraocular Lenses (IOLs).
February 5, 2020Medical DevicesFDA
Johnson & Johnson Surgical Vision Inc recalls 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
Hazard: Ophthalmic viscosurgical device may be difficult to remove from the eye, leading to increased postoperative intraocular pressure requiring additional intervention. Also, reports of clogging of phacoemulsion equipment tubing, which may lead to delay in the procedure or ocular injury.
July 10, 2019Medical DevicesFDA
Johnson & Johnson Surgical Vision Inc recalls Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item
Hazard: Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.
November 21, 2018Medical DevicesFDA
Johnson & Johnson Surgical Vision Inc recalls Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx
Hazard: Expired intraocular lenses were distributed.
October 10, 2018Medical DevicesFDA
Johnson & Johnson Surgical Vision Inc recalls OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers:
Hazard: Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI.