AcrySof™ IQ Vivity™ DAT315 (REF DAT315.205)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
- 7
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652427104), received between Oct 28, 2021 and May 13, 2024 — classified as 6 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
- Device Dislodged or Dislocated1
- Malposition of Device1
- Scratched Material1
Patient problems
- Visual Impairment4
- Blurred Vision3
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2024Adverse 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 PATIENT EXPERIENCED VISUAL DISTURBANCE. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS MODEL 11 MONTHS 23 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 19298604 ↗InjuryMay 26, 2023Malposition of Device; Malposition of Device
A PHYSICIAN REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT IS DISSATISFIED WITH HIS VISION (MONOCULAR DIPLOPIA). AUTOREFRACTION OD AT POST-OP MONTH 1 IS +0.50 -2.00 X 56. THE PATIENT WAS INTERESTED IN AN IOL EXCHANGE. THE PATIENT¿S TORIC IOL IS AROUND 25 DEGREES OFF AXIS. ADDITIONAL INFORMATION RECEIVED AND PHYSICIAN STATED THAT DID NOT END UP EXPLANTING THE IOL. ROTATED THE TORIC BACK INTO POSITION.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 17008742 ↗InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED POST IMPLANTATION OF LENS, PATIENT HAD REFRACTIVE SURPRISE/MYOPIC SURPRISE. THE LENS WAS EXPLANTED DURING A SECONDARY PROCEDURE AND EXCHANGED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 15427341 ↗InjuryFeb 9, 2022Defective Device; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Defective Device; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
A PATIENT REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DISLOCATED IN EYE. PATIENT HAD A REVISION. AS WELL AS A YAG (YTTRIUM ALUMINUM GARNET) PROCEDURE. HE BECAME NEARSIGHTED COMPLETELY. HE IS A DETRIMENT DRIVING, BUT IF HE DOESN'T DRIVE, HE WILL BE UNEMPLOYED! ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 13493796 ↗MalfunctionDec 7, 2021Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THERE WAS A SCRATCH ON THE LENS. THERE WAS CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12954202 ↗InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL, 142 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE RESIDUAL ASTIGMATISM WAS THE CONTRIBUTORY CAUSE.
Patient problems: Blurred Vision
MAUDE report 12787097 ↗InjuryOct 28, 2021Adverse 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 PATIENT EXPERIENCED BLURRED VISION AND HAD A REFRACTIVE ERROR ISSUES. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL, 105 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 12711507 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.