AcrySof™ IQ Vivity™ DFT415 (REF DFT415.235)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
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652422123), received between Oct 21, 2022 and Jul 18, 2024 — classified as 3 injuries, 2 malfunctions.
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. 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 Problem2
- Break1
- Defective Device1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Insufficient Information1
- Macular Edema1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER BILATERAL IMPLANTATION OF AN INTRAOCULAR LENS (IOL) LENS, 3 WEEKS AFTER THE FIRST EYE AND 2 WEEKS AFTER THE SECOND EYE IN POST-OPERATIVE VISIT, HER VISUAL ACUITY WORSENED AND SHE WAS DIAGNOSED WITH BILATERAL IRVINE GASS MACULAR EDEMA. THE PATIENT'S SECOND EYE WAS STILL UNRESOLVED WITH ACUITY OF 0.7. IN TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS 2 OF 2.
Patient problems: Blurred Vision; Macular Edema
MAUDE report 19770250 ↗InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE LENS WAS REMOVED AND REPLACED WITH A COMPANY LENS OF DIFFERENT MODEL BUT SAME DIOPTER IN A SECONDARY PROCEDURE.
Patient problems: Visual Impairment
MAUDE report 19078399 ↗MalfunctionJun 20, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON LENS NOTICED TINY BIT STANDS OUT THE REFLECTOR, THE SAME LENS WAS USED AND LEFT IN THE PATIENT'S EYE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17162235 ↗InjuryDec 12, 2022Break; Break
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LENS HAPTIC BROKEN WAS NOTED. ADDITIONAL INFORMATION WAS RECEIVED STATING SURGERY WAS INCOMPLETE ON THAT DAY. ANOTHER IOL WAS IMPLANTED IN THE NEXT DAY. THE CUSTOMER FOUND THE LENS HAPTIC BROKEN (INSIDE THE LENS CASE) AFTER THE PHACO STEP AND NO PATIENT CONTACT. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15958836 ↗MalfunctionOct 21, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON FOUND THAT, THERE IS FRACTURE IN THE OPTIC, FOR WHICH HE DECIDED TO EXPLANT THE LENS AND IMPLANT ANOTHER WITH THE SAME CHARACTERISTICS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15649187 ↗
Other Extended depth of focus intraocular lens devices
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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.