Events

Recall of Device Recall Peregrine 20 GA Endo Ocular Adjustable Laser Probe (Smart Flex)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Peregrine Surgical 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
    56271
  • Event Risk Class
    Class 2
  • Event Number
    Z-2399-2010
  • Event Initiated Date
    2010-07-19
  • Event Date Posted
    2010-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93106
  • 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 Laser - Product Code HQF
  • Reason
    Product did not have proper 510(k) clearance.
  • Action
    A recall letter is being sent to all affected accounts with instructions to return the recalled product to the recalling firm.

Device

Device Recall Peregrine 20 GA Endo Ocular Adjustable Laser Probe (Smart Flex)
  • Model / Serial
    Device numbers: PD720.50, PD720.52, PD723.50, PD723.52, PD725.50, PD725.52. Lot numbers 926287, 937391, 931335, 933355, 935370, 937390, 940422, 916188, 917184, 919211, 920228, 922244, 925269, 916189, 917185, 919216, 920229, 923245, 925272, 952026, 002048, 005069, 916186, 918196, 919205, 920240, 924268, 926285, 916184, 918203, 919208, and 922239.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to hospitals and eye surgery centers in Florida, Maryland, Missouri, North Carolina, Ohio, Pennsylvania, Texas.
  • Product Description
    Peregrine 20 GA Endo Ocular Adjustable Laser Probe
  • Manufacturer
    Peregrine Surgical Ltd

Manufacturer

Peregrine Surgical Ltd
  • Manufacturer Address
    Peregrine Surgical Ltd, 51 Britain Dr, New Britain PA 18901-5186
  • Manufacturer Parent Company (2017)
    Peregrine Surgical Ltd.
  • Source
    USFDA