Events

Recall of SofPort Advanced Optics Aspheric IOL

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bausch & Lomb Australia Pty Ltd.

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
    RC-2015-RN-00477-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00477-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    An investigation was initiated based on a limited number of complaints received for broken haptics during lens loading and insertion. this investigation resulted in bausch + lomb determining that a portion of a batch of haptic material is performing differently than other batches in terms of material elongation properties. a broken haptic during lens loading and insertion can result in surgical intervention (lens exchange) and increase the chance of damaging the eye. there have not been any reports of the haptic breaking after the surgery is complete.
  • Action
    Customers are advised to segregate the affected IOLs and return them to their Bausch + Lomb (Australia) (B&L;) representative. The B&L; representative will arrange for the provision of replacement stock. If replacement product is needed for a scheduled surgery before the full return can be processed, please contact the B&L; representative to expedite shipment of the IOL. Surgeons are advised that if they have already implanted an affected IOL, there is no indication that the implanted IOL presents a health issue or performance concern. Therefore, patients should be followed as per their usual standard of care. All reports of broken haptics have occurred during lens loading or insertion. This could result in the need to exchange the lens during surgery. This action has been closed-out on 11/08/2016.

Device

SofPort Advanced Optics Aspheric IOL
  • Model / Serial
    SofPort Advanced Optics Aspheric IOL, Model LI61AOLI61AO 13.00MM 22.5Serial No.:4464602066Expiry Date: 31-Aug-19LI61AO 13.00MM 23.50Serial No.: 4464642033Expiry Date: 31-Aug-19ARTG No: 98915
  • Manufacturer
    Bausch & Lomb Australia Pty Ltd

Manufacturer

Bausch & Lomb Australia Pty Ltd