AcrySof™ IQ Vivity™ DAT415 (REF DAT415.220)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652427951), received between Jun 21, 2021 and Nov 29, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 1 MONTH AFTER INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS SUBJECTIVE VISUAL DISTURBANCE/WRONG LENS POWER CHOSEN. ADDITIONAL INFORMATION WAS REQUESTED AND AT THIS POINT, NO FURTHER INFORMATION RECEIVED/AVAILABLE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 12880445 ↗MalfunctionJun 21, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A TEAR WAS NOTED AT THE HAPTIC OPTIC JUNCTION AFTER INSERTION OF THE IOL INTO THE ANTERIOR CHAMBER. THE IOL WAS LEFT IN THE EYE HOPING FOR BETTER. THE PATIENT HAD TEMPORALLY DISPLACED IOL AND VISION OF 20/60+1 (PH TO 20/32-1) WHICH WAS NOTED A WEEK AFTER THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12031259 ↗
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- 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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