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    ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 16, 2015

    FREESTYLE

    FDA Adverse Event
    Injury ·THERASENSE, INC.·Product code LFR·June 17, 2004

    Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.

    FDA Recall
    Terminated ·Alcon LenSx, Inc. 33 Journey Aliso·Product code OOE·March 14, 2014

    Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)

    FDA Recall
    Open, Classified ·AMO Manufacturing USA, LLC·Product code OOE·October 21, 2021

    Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

    FDA Recall
    Terminated ·Optimedica Corporation·Product code OOE·February 20, 2015

    OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.

    FDA Recall
    Terminated ·Abbott Medical Optics, Inc.·Product code OOE·February 20, 2015

    LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code OOE·April 14, 2016

    OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

    FDA Recall
    Terminated ·Johnson & Johnson Surgical Vision Inc·Product code OOE·May 9, 2018

    The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV(TM)Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

    FDA Recall
    Terminated ·SIE AG, Surgical Instrument Engineering Allmendstrasse·Product code OOE·January 21, 2018

    Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) - Catalys I 200-240V ~, 50/60 Hz, 15A, (2) 15A Resettable CB: Tested and complies with FCC Part 15 Class A. OptiMedica 1310 Moffett Park Drive Sunnyvale, CA 94089 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

    FDA Recall
    Terminated ·Optimedica Corporation·Product code OOE·December 20, 2013

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code OOE·November 2, 2016

    LENSX LASER SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON LENSX, INC.·Product code OOE·October 1, 2016

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code OOE·November 4, 2016

    LASIK

    FDA Adverse Event
    Injury ·UNK·Product code OOE·November 25, 2016

    LENSX LASER SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON LENSX, INC.·Product code OOE·November 18, 2016

    LENSX LASER SYSTEM

    FDA Adverse Event
    Injury ·ALCON LENSX, INC.·Product code OOE·November 18, 2016

    CATALYS SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code OOE·November 2, 2016

    LENSX LASER SYSTEM

    FDA Adverse Event
    Injury ·ALCON LENSX, INC.·Product code OOE·December 2, 2016

    LENSX LASER SYSTEM

    FDA Adverse Event
    Injury ·ALCON LENSX, INC.·Product code OOE·December 16, 2016