AcrySof™ IQ Vivity™ DFT015 (REF DFT015.120)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652421072), received between May 16, 2022 and Jan 12, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material1
Patient problems
- Blurred Vision2
- Headache1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 12, 2024Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED SCRATCH ON THE LENS AFTER IMPLANTING THE LENS INTO PATIENT'S EYE. THE LENS WAS LEFT INSIDE THE PATIENT'S EYE AND NOT REMOVED.
Patient problems: Insufficient Information
MAUDE report 18501450 ↗InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE LENS EXPLANTATION HAS BEEN SCHEDULED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Headache; Visual Impairment
MAUDE report 17478212 ↗InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT NOT ABLE TO SEE DEFINITION OF THE OBJECT INSIDE THE PLATE AND SHE CAN¿T SEE HER EYE LASHES WHEN ONE EYE CLOSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT PATIENT HAD SECOND EYE DONE AND EVERYONE WAS FINE, AND SHE HAD NOTICED THAT SHE JUST NEEDS A LITTLE MORE LIGHT THAN PRIOR TO SURGERY AS SHE COULD SEE EXTREMELY WELL UP CLOSE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 14405400 ↗
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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.