AcrySof™ IQ Vivity™ DAT415 (REF DAT415.225)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652427968), received between Mar 3, 2021 and Apr 14, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Opacification” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Material Opacification1
Patient problems
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Halo1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2022Material Opacification; Material Opacification
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD A LOT OF PROBLEMS WITH THE LENS. LAST TRIED FIX WAS POSTERIOR CAPSULOTOMY DID NOT FIX. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PROBLEM WITH THE LENS, IT IS NOT CLEAR, IT DOES NOT FUNCTION AS PROMISED. THE PATIENT COULD NOT SEE CLEARLY, STILL REQUIRE READING GLASSES FOR READING.
Patient problems: Blurred Vision
MAUDE report 14113497 ↗InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED VISION DIFFICULTY AND COTTON WOOL SPOTS (RETINA PROBLEM). THE LENS WAS EXPLANTED. NEW INFORMATION RECEIVED REPORTING THE PATIENT WAS SENT TO EXPLANT. POST OPERATION OF 7 DAYS PATIENT EXPERIENCED VISION DIFFICULTIES AND COTTON WOOL SPOTS (RETINAL PROBLEM).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment
MAUDE report 11921696 ↗InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS, DOUBLE VISION, RESIDUAL SCOTOPIC SHADOWING AND DYSPHOTOPSIAS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE THREE MONTHS POSTOPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Halo; No Code Available; Visual Impairment
MAUDE report 11405498 ↗
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- 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.