Johnson & Johnson Surgical Vision, Inc.
5 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Johnson & Johnson Surgical Vision, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-05-08FDA-DeviceClass IIJohnson & 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.
- 2024-01-24FDA-DeviceClass IITECNIS 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.
- 2023-08-09FDA-DeviceClass IITECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
- 2023-08-09FDA-DeviceClass IITECNIS 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.
- 2023-08-09FDA-DeviceClass IIVERITAS 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.
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