Lens, Intraocular, Phakic
FDA adverse event reports and recall history for lens, intraocular, phakic (product code MTA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 21,905
- Deaths
- 2
- Injuries
- 17,622
- Malfunctions
- 4,204
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.
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.
- 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: VICMO12.6. Phakic Intraocular lens.
Their is a potential that intraocular implant devices may not meet specifications.
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