AcrySof™ IQ Vivity™ DFT515 (REF DFT515.180)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 00380652422420), received between May 27, 2021 and Apr 19, 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 Problem2
- Break1
Patient problems
- Blurred Vision2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Corneal Scar1
- No Clinical Signs, Symptoms or Conditions1
- Posterior Capsule Opacification1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT AFTER CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION IN LEFT EYE, SHE WAS UNHAPPY WITH VISION AT ALL DISTANCES. THE CONSUMER UNDERWENT THE PROCEDURE APPROXIMATELY THREE YEARS AGO. DESPITE ADDRESSING THESE CONCERNS WITH HER SURGEON PRIOR TO UNDERGOING SURGERY ON THE SECOND EYE, THE SURGEON THOUGHT THE ISSUES WOULD BE RESOLVED WHEN THE SECOND EYE WAS DONE. ACCORDING TO HER THE DISTANCE VISION WAS SOMEWHERE AROUND 20/50. SHE ALSO MENTIONED SCAR TISSUE BUILT UP AND A YTTRIUM-ALUMINUM-GARNET (YAG) LASER WAS DONE IN HER LEFT EYE.
Patient problems: Blurred Vision; Corneal Scar; Posterior Capsule Opacification
MAUDE report 19142470 ↗InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, VISION WAS CLEARER BUT AFTER ONE WEEK, IT TURNED FOGGY AND THE EYE CONSTANTLY SEGREGATES CLEAR TEARS, WHICH CONTRIBUTED TO MAKING BLURRED VISION. DOCTORS PRESCRIBED NONSTEROIDAL ANTI-INFLAMMATORY DRUGS AND ANTI-ALLERGIC EYE DROPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Impairment
MAUDE report 14675976 ↗MalfunctionMay 27, 2021Break; Break
A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), A SMALL DIVET WAS NOTED ON POSTERIOR SURFACE OF THE IOL. THE LENS WAS REMAINED IMPLANTED AND SURGEON NOT CONCERNED REGARDING VISUAL ACUITY OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11896981 ↗
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- 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.