AcrySof™ IQ Vivity™ DAT315 (REF DAT315.165)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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652427029), received between Feb 14, 2022 and Feb 24, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Application Program Problem: Power Calculation Error” (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
- Application Program Problem: Power Calculation Error1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Blurred Vision4
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2022Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT, THE LENS WAS EXPLANTED DUE TO WRONG LENS. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE. CLINICAL REASON WAS MENTIONED AS UNABLE TO SEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Blurred Vision
MAUDE report 13591870 ↗InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED DUE TO WRONG LENS. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE. CLINICAL REASON WAS MENTIONED AS UNABLE TO SEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Blurred Vision
MAUDE report 13578237 ↗InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OPERATING ROOM SUPERVISOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRED VISION, ANISOMETROPIA AND REFRACTIVE SURPRISE. 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 13522092 ↗InjuryFeb 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO SEE. THE CLINICAL REASON FOR EXPLANT WAS USED WRONG LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 13521992 ↗
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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.