POEClass 3
Extended Depth Of Focus Intraocular Lens
FDA adverse event reports and recall history for extended depth of focus intraocular lens (product code POE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,794
- Deaths
- 0
- Injuries
- 4,680
- Malfunctions
- 1,114
Reports per year
11016
75417
79918
73519
34720
59821
63522
55123
57724
50125
18726
Source: FDA adverse event reports by year received, 2016–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2023-08-03Open, ClassifiedUnder Investigation by firm
TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only
Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fiducial marks.
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