Staar Surgical Company
FDA adverse event reports naming Staar Surgical Company as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: STAAR SURGICAL COMPANY.
- Total reports
- 41,734
- Deaths
- 3
- Injuries
- 30,936
- Malfunctions
- 10,617
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Lens, Intraocular, PhakicMTA19,318
- Phakic Toric Intraocular LensQCB17,258
- Intraocular LensHQL4,576
- Lens, Guide, IntraocularKYB392
- Folders And Injectors, Intraocular Lens (Iol)MSS172
- Unit, PhacofragmentationHQC9
- Lens, Intraocular, Toric OpticsMJP4
- Intraocular Pressure Lowering ImplantOGO3
- Instrument, Vitreous Aspiration And Cutting, Ac-PoweredHQE1
- Implant, Eye ValveKYF1
Recent recalls
- 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.
- 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.
Monitor Staar Surgical Company automatically
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