AcrySof™ IQ Vivity™ DFT015 (REF DFT015.105)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652421041), received between Jun 7, 2022 and Mar 2, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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 Problem1
- Failure to Unfold or Unwrap1
- Scratched Material1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Failure to Unfold or Unwrap
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS CANNOT FULLY EXPAND. THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 24478970 ↗MalfunctionJun 27, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL STATED THAT, SURGEON OBSERVED A SCRATCH ON THE OPTIC SURFACE AFTER IMPLANTATION. NEEDED TO EXPLANT THE LENS AND REPLACED WITH ANOTHER UNSPECIFIED LENS ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346249 ↗InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MONOFOCAL DIPLOPIA AND SMALL MYOPIC REFRACTION. ADDITIONAL INFORMATION RECEIVED STATED THAT SYMPTOM DID NOT AFFECT THE CAPABILITIES OF THE PATIENT TO PERFORM DAILY ACTIVITIES. HOWEVER, DIPLOPIA CAUSED A LOSS OF 2 LINES OR MORE OF BCVA (BEST CORRECTED VISUAL ACUITY). SURGEON ALSO STATED THAT RECOVERY TO 9/10 (WITHOUT CORRECTION) AT DAY 1 FOLLOWING A POST-OPERATIVE EXPLANTATION FOR A MONOFOCAL IOL. SURGEON STATED THAT CORTICAL ACQUISITION OF MULTIFOCALITY WAS NOT OPTIMAL IN THE PATIENT. PATIENT ALSO TRIED A PROGRESSIVE LENS WHICH WAS FAILURE. THE PATIENT HAD NO MORE VISION PROBLEM. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 14619405 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.