Aberrometer, Ophthalmic
FDA adverse event reports and recall history for aberrometer, ophthalmic (product code NCF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 639
- Deaths
- 0
- Injuries
- 335
- Malfunctions
- 304
Reports per year
Source: FDA adverse event reports by year received, 2003–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- TerminatedSoftware design
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.
- TerminatedSoftware design
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Some ORA Carts have the potential to return an incorrect IOL power measurement during cataract surgery. This issue appears to have been caused by a software coding error that results in the lens coefficients for an IOL model being downloaded from the Alcon server in an incorrect order.
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