Hoya Surgical Optics, Inc.
FDA adverse event reports naming Hoya Surgical Optics, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: HOYA SURGICAL OPTICS, INC..
- Total reports
- 1,523
- Deaths
- 0
- Injuries
- 1,009
- Malfunctions
- 510
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
Recent recalls
- 2011-07-14TerminatedPMA
iSymm Intraocular Lens (Model FC-60AD) The Hoya iSymm Model FC-60AD Intraocular Lens (IOL) is an ultraviolet-light absorbing posterior chamber intraocular lens designed to be implanted posterior to the iris where the lens will replace the optical function of the natural crystalline lens. However, accommodation will not be replaced. The optic of this lens is designed to produce negative spherical aberration. The Hoya iSymm Model FC-60AD Intraocular Lens is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval.
- 2011-07-14TerminatedPMA
iSert Intraocular Lens (Model PC-60AD)
The recall was initiated because Hoya Surgical Optics has confirmed that the iSymm Intraocular Lens (Model FC-60AD) and iSert Intraocular Lens (Model PC-60AD) have been sold and marketed with out an FDA approval.
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