AcrySof™ IQ Vivity™ DAT015 (REF DAT015.245)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652424721), received between Nov 23, 2021 and Mar 6, 2024 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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 Problem5
- Defective Device1
Patient problems
- Blurred Vision3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Corneal Edema2
- Inflammation2
- Visual Disturbances2
- Visual Impairment2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2024Adverse 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 PERIPHERAL SHADOW EVEN AFTER DOING A LENS REPOSITION. CLINICAL REASON WAS MENTIONED AS NEGATIVE DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL SIX MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 18844376 ↗InjuryFeb 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REPORTED THAT SHE STILL HAD THE SHADOW AND COULD NOT SEE. THE PATIENT'S SURGERY AND IOL APPEAR PRISTINE AND WELL CENTERED. AFTER 3-4 MONTHS OF IOL IMPLANTATION, SHE DEVELOPED TEMPORAL CRESCENT DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS RECEIVED STATING IS UNHAPPY WITH UNEXPECTED OUTCOME AND NEGATIVE DYSPHOTOPSIA. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 16359584 ↗InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT THE PATIENT HAD EDEMA, INFLAMMATION AND DESCEMET'S FOLD WHICH LED TO DECREASED VISION POSTOPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Inflammation
MAUDE report 15508342 ↗InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EDEMA AND INFLAMMATION WHICH LED TO DECREASED VISION POSTOPERATIVELY. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision; Corneal Edema; Inflammation
MAUDE report 15508207 ↗MalfunctionFeb 7, 2022Defective Device; Defective Device
A CONSUMER REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS REPORTED AS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13472408 ↗InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE ARE MULTIPLE PATIENTS HAVING MYOPIC OUTCOMES AFTER LENS IMPLANTATION. ADDITIONAL INFORMATION WAS PROVIDED. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO CLINICAL ISSUES (UNDER CORRECTED ISSUES) IMPACTING PREOPERATIVE MEASUREMENTS AND POSTOPERATIVE VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment
MAUDE report 12859794 ↗
Other Extended depth of focus intraocular lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- 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.