• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Recall: Hoya Surgical Optics pulls intraocular lenses amid adverse event reports

Recall: Hoya Surgical Optics pulls intraocular lenses amid adverse event reports

April 5, 2013 By Arezu Sarvestani

Hoya Surgical Optics logo

Singapore-based Hoya Surgical Optics recalled 5 models of its intraocular lenses after receiving reports of higher-than expected rates of inflammation from doctors in several countries.

Healthcare regulators in the U.K. and in Australia have both reported the recall, asking doctors to stop using the implants immediately.

The company initially suspended certain shipments of the intraocular implants while it investigated adverse event reports tied to 3 of its lenses: the NY‐60, iSert 250 and iSert 251 IOLS.

"The patient data shared with us showed sterile,resolved reports without any permanent injury following appropriate treatment in all but very few cases," according to a Hoya warning letter. "An extensive review of our manufacturing process revealed that some products had trace residual foreign particulates on them. We have been unable to definitely determine if they were linked to the adverse events but the potential may exist."

The adverse event incident rate is between 0.03%-0.3% worldwide, according to U.K. healthcare authorities. Patients may experience pain or redness or loss of vision in the eye.

As a precautionary measure the company initiated a voluntary recall of the 3 lenses in question as well as 2 others that follow a similar manufacturing process: Toric 311, and iSert Toric 351.

Hoya is implementing changes to its manufacturing process to mitigate future problems, and plans to resume manufacturing of all 5 lenses once it gets the go-ahead from regulators.

Filed Under: News Well, Optical/Ophthalmic, Recalls Tagged With: Hoya Surgical Optics

More recent news

  • Neuralink files to raise $649M in new equity offering
  • BofA: Surgical robot remanufacturing not a major setback for Intuitive
  • InspireMD wins CE Mark approval for CGuard Prime
  • Philips reports first cases for VeriSight Pro 3D ICE catheter in Europe
  • Ceryx Medical raises $15M to support bioelectronic pacemaker

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy