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Johnson & Johnson Surgical Vision, Inc. FDA Recalls
14 recalls on file across devices, 0 of them Class I and 12 still open. Matched by name to JNJ.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) HEALON EndoCoat PRO, REF: 10Class IIJul 31, 2026Surgical instructions sent for viscoelastic products used du |
| Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irClass IIMar 14, 2024Due to a manufacturing variation of the irrigation sleeves w |
| TECNIS Toric II OptiBlue IOL Models ZCWClass IIDec 12, 2023Due to intraocular lens containing an angle out of specifica |
| TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx OnlyClass IIJul 6, 2023Their is a potential that intraocular lenses (IOLs) were ma |
| TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx OnlyClass IIJul 6, 2023Their is a potential that intraocular lenses (IOLs) were ma |
| VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs (VRT-AF)Class IIMay 30, 2023Weld protrusion/physical gap between the housing and pack co |
| FUSION Dual Pump Packs, REF: OPO73Class IIDec 7, 2022Weld protrusion/physical gap between the housing and phaco p |
| Veritas Advanced Infusion Packs, REF: VRT-AIClass IIDec 7, 2022Weld protrusion/physical gap between the housing and phaco p |
| Single-Use Packs, REF: OPO80Class IIDec 7, 2022Weld protrusion/physical gap between the housing and phaco p |
| THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electropClass IISep 7, 2022Manufacturing error resulted in potential contamination of B |
| Veritas Advanced Infusion Packs. Used in ophthalmic procedures.Class IISep 1, 2022As a result of returned product complaints for Veritas Phaco |
| TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,Class IIApr 6, 2022Potential breach in the sterility barrier for tray ring cove |
| TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS SimpliClass IIAug 6, 2021Nonconforming product was distributed in error. Product was |
| TECNIS Toric 1-Piece IOL, Model Number: ZCT150 +23.5D SE 1.50D CYL - Product Usage: intended to be placed in the capsulaClass IIJan 27, 2021Due to the release of nonconforming Intraocular Lenses (IOLs |