Phakic Toric Intraocular Lens
FDA adverse event reports and recall history for phakic toric intraocular lens (product code QCB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 18,073
- Deaths
- 1
- Injuries
- 15,022
- Malfunctions
- 3,050
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-03-02Open, ClassifiedProcess control
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
- 2023-12-01Open, ClassifiedSoftware design (manufacturing process)
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-01Open, ClassifiedSoftware design (manufacturing process)
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-01Open, ClassifiedSoftware design (manufacturing process)
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
- 2023-12-01Open, ClassifiedSoftware design (manufacturing process)
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
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