AcrySof™ IQ Vivity™ DFT515 (REF DFT515.175)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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652422413), received between Nov 26, 2021 and Jun 12, 2024 — classified as 2 injuries, 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. 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
- Break1
- Contamination1
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 12, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE NEXT DAY DURING THE REVIEW SURGEON OBSERVED THAT IOL BROKE 25 DEGREES, SO SURGEON DECIDED TO EXPLANT IT AND IMPLANT AN ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19518034 ↗InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CLINICAL MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION, ASTIGMATISM, IRREGULAR, LEFT EYE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 14303651 ↗MalfunctionNov 26, 2021Contamination; Contamination
ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE HOSPITAL WAS NOT ABLE TO DESCRIBE THE FOREIGN SUBSTANCE, SO IT WAS DIFFICULT TO CLARIFY THE FOREIGN SUBSTANCE. IT WAS ALSO STATED THAT FACILITY DOES NOT REMEMBER THE EVENT CLEARLY. IT WAS UNKNOWN IF THERE WAS A PATIENT CONTACT OR NOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12878206 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.