Events

Recall of Device Recall Common Name: LenSx Laser System.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alcon LenSx, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67755
  • Event Risk Class
    Class 2
  • Event Number
    Z-1445-2014
  • Event Initiated Date
    2014-03-14
  • Event Date Posted
    2014-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126213
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ophthalmic femtosecond laser - Product Code OOE
  • Reason
    Alcon lensx received reports of unexpected downward motion of the gantry.
  • Action
    Alcon LenSx Inc advised customers of a Medical Device Correction being initiated for specific serial numbers of the LenSx Laser System for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation. Alcon sent customer notification letters via mail during the week of March 17, 2014. The letter titled "Medical Device Correction", advised customers of the correction and provided: the product's description with serial number(s), description of the potential condition, advise on action to be taken by the user, transmission of the notice, and a contact reference person. The letter also contained a section for customers to sign and return the page of the Notice to Alcon.

Device

Device Recall Common Name: LenSx Laser System.
  • Model / Serial
    (US) Serial Numbers:  0311-A007, 0511-A013, 0611-A017, 0611-A018, 0711-A021, 0811-A026, 0811-A027, 0811-A033, 0811-A035, 0911-A039, 0911-A045, 1011-A050, 1011-A062, 1111-A067, 1111-A073, 1111-A077, 1111-A080, 1111-A085, 1211-A086, 1211-A087, 1211-A088, 1211-A090, 0112-A099, 0212-A111, 0212-A116, 0212-A117, 0312-A126, 0312-A130, 0312-A135, 0412-A147, 0412-A152, 0412-A153, 0412-A155, 0512-A163, 0512-A167, 0512-A169. (International) Serial Numbers: 0611-A020, 0711-A022, 0711-A025, 0811-A030, 0811-A031, 0811-A032, 0811-A037, 0911-A038, 0911-A040, 0911-A041, 0911-A042, 1011-A053, 1011-A054, 1011-A055, 1011-A060, 1111-A069, 1111-A071, 1111-A072, 1111-A074, 1111-A075, 1111-A081, 1111-A082, 1211-A091, 1211-A094, 0112-A106, 0112-A107, 0112-A108, 0112-A109, 0212-A118, 0312-A121, 0312-A122, 0312-A123, 0312-A127, 0312-A132, 0512-A158, 0512-A160, 0512-A162, 0512-A164, 0512-A166.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation.
  • Manufacturer
    Alcon LenSx, Inc.

Manufacturer

Alcon LenSx, Inc.
  • Manufacturer Address
    Alcon LenSx, Inc., 33 Journey, Aliso Viejo CA 92656-5346
  • Manufacturer Parent Company (2017)
    Novartis Ag
  • Source
    USFDA