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    Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. The lens is preloaded and pre-assembled in the delivery system. The TECNIS SIMPLICITY" Delivery System Model DIB00 contains the TECNISEyhance" IOL, which is a one-piece, foldable, posterior chamber lens with an overall diameter of 13.0 mm and an optic diameter of 6.0 mm. The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled and touch-free method of delivering the lens into the eye. Component: No

    FDA Recall
    Open, Classified ·AMO Puerto Rico Manufacturing, Inc. Rd #·Product code HQL·February 19, 2026

    Akreos, SKU: AO60P0300. Akreos intraocular lenses

    FDA Recall
    Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code HQL·June 6, 2025

    Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL, All models starting with ETE; enVista Aspire Toric IOL, All models starting with ETA;

    FDA Recall
    Open, Classified ·Bausch & Lomb Surgical, Inc.·Product code HQL·March 27, 2025

    TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code HQL·July 6, 2023

    RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +21.00D, Sph: +21.00D.

    FDA Recall
    Open, Classified ·Rayner Intraocular Lenses Ltd 10 Dominion Way Worthing United Kingdom·Product code HQL·May 13, 2022

    Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P

    FDA Recall
    Open, Classified ·WOM World Of Medicine AG Alte Poststr. 11 Ludwigsstadt Germany·Product code HIG·July 17, 2023

    Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

    FDA Recall
    Open, Classified ·Synthes USA HQ, Inc.·Product code KTT·October 12, 2012

    LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01

    FDA Recall
    Open, Classified ·Waldemar Link GmbH & Co. KG (Corp. Hq.) Barkhausenweg 10 Hamburg Germany·Product code LXH·September 11, 2024