Staar Surgical
FDA adverse event reports naming Staar Surgical as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: STAAR SURGICAL.
- Total reports
- 2,480
- Deaths
- 0
- Injuries
- 1,456
- Malfunctions
- 941
Reports per year
Source: FDA adverse event reports by year received, 2004–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2026-06-18Open, ClassifiedSoftware design
Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
- 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:VICM5_12.1. Phakic 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: VICM5_12.6. Phakic 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: VICM5_13.2. Phakic 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: VICM5_13.7.Phakic 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: VICMO12.1. Phakic 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: VICMO13.2. Phakic 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_12.1. 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.
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