AcrySof™ IQ Vivity™ DAT415 (REF DAT415.260)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652428033), received between Jan 17, 2023 and Jan 17, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- Capsular Bag Tear1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE CAPSULE RUPTURE, DOES NOT KNOW IF THE LENS CAUSED THE RUPTURE. IT WAS A VERY SMALL EYE, THE CAPSULE APPEARED INTACT UPON IMPLANTING THE LENS, THEN WRINKLED AND THE LENS STARTED TO GO TO THE VITREOUS. HE WAS ABLE TO REMOVE THE LENS AND REPLACE IT WITH A 3-PIECE LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, RENT IN CAPSULE RESULTING IN CHANGING FROM A VIVITY TO A MONOFOCAL LENS. THE PATIENT ALSO REQUIRED POSTOP EYEDROPS BECAUSE OF THE TEAR IN THE CAPSULE. PATIENT WAS LEFT WITH RESIDUAL ASTIGMATISM. PATIENT'S POSTOP VISUAL ACUITY IS 20/25 AT HIS LAST VISIT. THE PATIENT RIGHT EYE IS A LAZY EYE AND HE RELIES MORE ON HIS LEFT EYE. HE WAS SENT TO HIS REFERRING OPTOMETRIST TO GET GLASSES AS NEEDED TO CORRECT HIS REMAINING ASTIGMATISM. THE SURGEON¿S PROGNOSIS WAS GOOD, BUT MAY NEED GLASSES NOW FOR ASTIGMATISM AND NEAR VISION.
Patient problems: Blurred Vision; Capsular Bag Tear; Visual Impairment
MAUDE report 16186517 ↗
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- 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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