CooperVision Announces Expanded Recall of Avaira Line of Contact Lenses
CooperVision announced today that it is expanding its worldwide recall of the Avaira brand product line of contact lenses to include a limited number of lots of Avaira Sphere contact lenses. In continued collaboration with FDA, CooperVision is expanding the recall because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue. All told, it’s estimated the recall will cost CooperVision $23.2million. It’s likely this cost is inflated because of the way the recall was mismanged.
The Recall
The presence of the residue (silicone oil) on Avaira Sphere contact lenses may cause hazy vision or discomfort, severe eye pain or eye injuries requiring medical treatment. Not everyone experiences the same symptoms.
Food Court previously reported the recall (here and here), which began nearly two months after problems were first announced. The FDA put pressure on CooperVision amid a quiet recall and amped up public warnings about more than half a million recalled contact lenses, urging users to return the potentially defective products and to seek medical care if they show symptoms of harm.
The Response
Overall the recall has been handled poorly. The expanded recall is evidence that CooperVision did not investigate the issue to determine its root cause or if it affected other lots distributed. When confronted with a recall manufacturers/distributors/importers should consult with legal counsel who can quickly issue proper public warnings and work with facility staff to identify the reason for the recall and whether it impacted other products. The quicker counsel is brought on the more that can be saved and the better a brand could be protected.
- No comments Posted in: Medical Device News (FDA), Medical Device Recall Tags: 6-Pack Carton, Avaira, Avaira Toric contact lenses, Avaira Toric recall, Blister Label, contact lens recall, contacts, Cooper Vision, CooperVision Inc., CooperVision Inc. recall, Costco, Fairport, FDA, Lens Crafters, Recall, Toric, Wal-Mart
Related posts
-
EU Looks to Tighten Medical Device Safety With Implant Registry | No comments
In the wake of high-level scandals in the EU, including …
-
FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported products | No comments
The FDA’s Global Engagement Report shed light on the volume …
-
Report: Internal FDA Reports Slams European Regulation of Medical Devices as Ineffective | 2 comments
The FDA has criticized Europe’s review process for medical devices …
-
Senators Seek to Improve Safety of Children’s Medications and Medical Devices | No comments
A bipartisan team of Senators announced today new legislation aimed at improving the safety …
Leave a comment