Johnson & Johnson Surgical Vision, Inc. Recalls

All product recalls associated with Johnson & Johnson Surgical Vision, Inc..

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Recall Summary

Total Recalls

11

Past Year

0

Class I (Serious)

0

Most Recent

Mar 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–11 of 11 recalls

Johnson & Johnson Surgical Vision, Inc.: Johnson & Johnson VISION Reusable LAMINAR High Flow Irrig...

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.

Moderate

FDAMar 14, 2024Nationwide• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.: 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.

Moderate

FDADec 12, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Moderate

FDAJul 6, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.: TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00,...

Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.

Moderate

FDAJul 6, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.: VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Adva...

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.

Moderate

FDAMay 30, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.: 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.

Moderate

FDADec 7, 2022FL, IL, MN +5 more• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.: 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.

Moderate

FDADec 7, 2022FL, IL, MN +5 more• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.: 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.

Moderate

FDADec 7, 2022FL, IL, MN +5 more• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.: THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Cathet...

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.

Moderate

FDASep 7, 2022Nationwide• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision, Inc.: Veritas Advanced Infusion Packs. Used in ophthalmic proce...

As a result of returned product complaints for Veritas Phaco packs related to broken or cracked irrigation luer due to a manufacturing issue.

Moderate

FDASep 1, 2022AL, AZ, AR +22 more• Johnson & Johnson Surgical Vision, Inc.

Johnson & Johnson Surgical Vision Inc: TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COV...

Potential breach in the sterility barrier for tray ring covers.

Moderate

FDAApr 6, 2022Nationwide• Johnson & Johnson Surgical Vision Inc

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Johnson & Johnson Surgical Vision, Inc. Recalls

Recall Summary

Johnson & Johnson Surgical Vision, Inc.: Johnson & Johnson VISION Reusable LAMINAR High Flow Irrig...

Johnson & Johnson Surgical Vision, Inc.: TECNIS Toric II OptiBlue IOL Models ZCW

Johnson & Johnson Surgical Vision, Inc.: TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

Johnson & Johnson Surgical Vision, Inc.: TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00,...

Johnson & Johnson Surgical Vision, Inc.: VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Adva...

Johnson & Johnson Surgical Vision, Inc.: Veritas Advanced Infusion Packs, REF: VRT-AI

Johnson & Johnson Surgical Vision, Inc.: FUSION Dual Pump Packs, REF: OPO73

Johnson & Johnson Surgical Vision, Inc.: Single-Use Packs, REF: OPO80

Johnson & Johnson Surgical Vision, Inc.: THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Cathet...

Johnson & Johnson Surgical Vision, Inc.: Veritas Advanced Infusion Packs. Used in ophthalmic proce...

Johnson & Johnson Surgical Vision Inc: TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COV...