AcrySof™ IQ Vivity™ DAT315 (REF DAT315.180)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652427050), received between Mar 23, 2022 and Dec 31, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Scratched 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Scratched Material1
Patient problems
- Visual Disturbances2
- Visual Impairment2
- Blurred Vision1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT STILL HAD GLARE, AND VISION WAS NOT AS CRISP. THE LENS WAS REMOVED AND REPLACED WITH A NON-COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS CITED AS MILD RESIDUAL REFRACTIVE ERROR. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, IN THE SURGEON'S OPINION, THE PRODUCT WAS RESPONSIBLE FOR THE PATIENT'S EVENTS, THE PATIENT EXPERIENCED GHOSTING AND BLURRY VISION SINCE INITIAL PROCEDURE. THE PATIENT'S SYMPTOMS WERE RESOLVED, AND THE SURGEON REPORTED A GOOD PROGNOSIS. THERE WAS NO FURTHER IMPACT TO THE PATIENT.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 23934655 ↗InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT, IT WAS STARTED THAT HER RIGHT EYE WAS STILL NOT GREAT AND READING WAS ONLY OK AT ARMS LENGTH.
Patient problems: Visual Disturbances
MAUDE report 17818548 ↗MalfunctionApr 25, 2023Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANTATION SCRATCH WAS NOTED ON THE LENS. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16804744 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISUAL OUTCOME AND MYOPIC SURPRISE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 6 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 13856985 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.