AcrySof™ IQ Vivity™ DAT415 (REF DAT415.205)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
All models of AcrySof IQ Vivity (225)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652427920), received between Oct 21, 2022 and Oct 26, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Malposition of Device1
Patient problems
- Blurred Vision1
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A DOCTOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FILAMENT WAS REMOVED FROM THE POSTERIOR OF THE LENS, ON THE OPTIC JUST INFERIOR TO THE HAPTIC OPTIC JUNCTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15674160 ↗MalfunctionOct 21, 2022Malposition of Device; Malposition of Device
A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS IMPLANTATION, SHE HAD GLARE AT NIGHT AND VISION WAS CLOUDY. THE VISION WAS WORSE THAN BEFORE SURGERY. SHE WAS NOT HAPPY WITH BLURRY VISION AND WAS USING OLD PAIR OF GLASSES THAT SHE CAN SEE BETTER WHILE WEARING. SHE STATED THAT HER RETINA DOCTOR RECENTLY WHO TESTED HER VISION AND THOUGHT THE LENS WAS ABOUT 15-20% OFF IN ROTATION. SHE ALSO STATED THAT, SHE WOULD POSSIBLY HAD A LASER VISION CORRECTION FOR THE REFRACTIVE ERROR.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 15649384 ↗
Other Extended depth of focus intraocular lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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