AcrySof™ IQ Vivity™ DAT015 (REF DAT015.170)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652424578), received between May 19, 2021 and Oct 30, 2024 — classified as 6 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (4 reports).
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 Problem6
- Scratched Material4
- Defective Device1
Patient problems
- Blurred Vision4
- Insufficient Information3
- Visual Impairment2
- Corneal Edema1
- Dry Eye(s)1
- Eye Pain1
- Foreign Body Sensation in Eye1
- Headache1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, INTRAOCULAR LENS RETURNED WITH A NOTE SCRATCHED ON THE BOX. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20569874 ↗InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT NOT SATISFIED WITH DISTANCE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT NOT SATISFIED WITH DISTANCE VISION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 18834835 ↗InjuryMay 8, 2023Adverse 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 BLURRY VISION/DIFFICULTY WITH VISION, CANNOT READ WELL AND HAVING TROUBLE WITH INTERMEDIATE VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH MONOFOCAL LENS. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT WAS ONLY CORRECTABLE TO DISTANCE 20/30, INTERMEDIATE 20/40. READING JIO. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS TWO OF TWO.
Patient problems: Blurred Vision
MAUDE report 16887379 ↗MalfunctionApr 27, 2023Scratched Material; Scratched Material
A NURSE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED AND LEFT IMPLANTED IN PATIENT EYE.
Patient problems: Insufficient Information
MAUDE report 16821781 ↗InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NEARSIGHTED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MYOPIC. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 16687739 ↗InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE DUE TO MECHANICAL COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14915866 ↗InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Scratched Material; Adverse Event Without Identified Device or Use Problem; Scratched Material
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS A SCRATCH OR SMUDGE ON THE LENS AND THE PATIENT HAD EXPERIENCED EYE PAIN AND FOREIGN BODY SENSATION WHICH HAD EFFECTED THE VISION. THE LENS WAS EXPLANTED FOR A REPLACEMENT LENS IN A SECONDARY PROCEDURE.
Patient problems: Corneal Edema; Dry Eye(s); Eye Pain; Foreign Body Sensation in Eye; Headache; Irritability; Visual Disturbances
MAUDE report 12859719 ↗MalfunctionNov 15, 2021Defective Device; Defective Device
A NON HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12811760 ↗InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED AN EXPLANTED INTRAOCULAR LENS WITH A PATIENT REASON FOR EXPLANT OF, UNHAPPY WITH VISUAL OUTCOME AND A CLINICAL REASON FOR EXPLANT OF MECHANICAL COMPLICATION OF LENS (OS). ADDITIONAL INFORMATION REQUESTED.
Patient problems: Visual Impairment
MAUDE report 12197565 ↗MalfunctionMay 19, 2021Scratched Material; Scratched Material
AN ACCOUNT MANAGER REPORTED ON BEHALF OF SURGEON. DR NOTED SCRATCH ON CENTER OF IOL ON DAY 1 POST OP. SHE DIDN'T SEE SCRATCH ON THE DAY OF SURGERY.
Patient problems: Blurred Vision
MAUDE report 11847253 ↗
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.