AcrySof™ IQ Vivity™ DFT415 (REF DFT415.145)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
- 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 00380652421942), received between Jan 4, 2023 and Jun 29, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information2
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
ACCORDING TO ADDITIONAL INFORMATION, THE INTRAOCULAR LENS (IOL) EXCHANGE WAS DONE IN PATIENT'S LEFT EYE, SINCE PATIENT COMPLAINED ABOUT HAVING VERY POOR VISUAL OUTCOME. THE PATIENT REPORTEDLY MADE A GOOD INITIAL RECOVERY, BUT THE VISUAL ACUITY REMAINED POOR.
Patient problems: Insufficient Information; Visual Impairment
MAUDE report 17225157 ↗MalfunctionJan 4, 2023Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT THERE WERE FAULTY LENSES.
Patient problems: Insufficient Information
MAUDE report 16093190 ↗
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- 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.