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NAAClass 3

Lens, Intraocular, Accommodative

FDA adverse event reports and recall history for lens, intraocular, accommodative (product code NAA), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
1,402
Deaths
0
Injuries
1,382
Malfunctions
15

Reports per year

11
12
13
14
15
16
17
18
19
20
21
22
23
24
26

Source: FDA adverse event reports by year received, 20112026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2012-01-11TerminatedNonconforming Material/Component

    Crystalens Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The Crystalens is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia.

    Bausch + Lomb voluntary initiated the recall due to a physician complaint of haze on the Crystalens AO which was visualized using an angled beam from a slit lamp during the post-operative examination.

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