FDA (Devices) recall action 93312
The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.
Their is a potential that intraocular implant devices may not meet specifications.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Staar Surgical Company is recalling 9 EVO VISIAN intraocular lenses due to potential specification non-compliance. The affected devices were distributed to 40 US states.
Staar Surgical is recalling 15 EVO+VISIAN Implantable Collamer Lens devices due to potential specification failures. The devices may not meet design specifications.
Staar Surgical recalls EVO VISIAN implantable intraocular lenses because they may not meet specifications. Patients with these implants should contact their ophthalmologist.
Staar Surgical Company is recalling EVO VISIAN Implantable Collamer Lens devices due to potential specification defects. Two units distributed across the United States are affected.
Staar Surgical is recalling 20 units of the EVO+VISIAN Implantable Collamer Lens due to a potential that implanted devices may not meet specifications. The recall affects units distributed across multiple US states.
Staar Surgical is recalling 3 units of its EVO+VISIAN Implantable Collamer Lens (phakic toric) due to a potential that devices may not meet specifications. No illnesses or injuries have been reported.
Staar Surgical recalls six EVO+VISIAN intraocular lens implants due to potential specification non-compliance. The affected units were distributed across 38 US states.
Staar Surgical is recalling EVO +VISIAN Implantable Collamer Lens devices due to a potential that the devices may not meet specifications. Patients should consult their eye care provider.
Staar Surgical recalls 51 EVO+VISIAN intraocular lenses due to potential specification non-compliance. Affected devices were distributed across multiple U.S. states.
Staar Surgical is recalling 133 units of EVO+VISIAN intraocular lenses that may not meet manufacturing specifications. The affected devices were distributed across multiple U.S. states.
Staar Surgical is recalling 11 EVO+VISIAN implantable collamer lenses distributed across 38 US states because they may not meet manufacturing specifications. No illnesses or injuries have been reported.