AcrySof™ IQ Vivity™ DFT015 (REF DFT015.145)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652421126), received between Nov 30, 2021 and Aug 23, 2024 — classified as 8 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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 Problem7
- Crack1
- Insufficient Device Problem Information1
- Scratched Material1
Patient problems
- Blurred Vision4
- Insufficient Information3
- Visual Disturbances3
- Visual Impairment3
- Eye Pain2
- Headache2
- Dry Eye(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPON FURTHER REVIEW OF THE COMPLAINT, THE PATIENT HAD EXPERIENCED BLURRY VISION, GLARE, PAIN AND HEADACHES AFTER LENS IMPLANTATION. THE PATIENT WAS UNHAPPY AFTER IMPLANTATION. HOWEVER, THE LENS WAS NOT EXPLANTED.
Patient problems: Blurred Vision; Eye Pain; Headache; Visual Disturbances
MAUDE report 20053597 ↗InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT LENS WAS NOT EXPLANTED AND NO PLAN TO EXPLANT.
Patient problems: Blurred Vision; Eye Pain; Headache; Visual Disturbances
MAUDE report 20037193 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT STATES SINCE THEY TOOK THE PATCH OFF SHE SEES A BLURRED, SMUDGE ON THE PERIPHERY OF HER VISION. WHEN PATIENT LOOKS STRAIGHT IT IS PRETTY CLEAR, BUT WHEN PATIENT LOOKS LEFT OR RIGHT SHE SEES THE SMUDGE SPOT. PATIENT SURGEON SAW HER AT ONE DAY POST OP AND TOLD HER EVERYTHING WAS FINE BUT HER EYES WERE DRY AND TO USE ARTIFICIAL TEARS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Dry Eye(s); Visual Disturbances
MAUDE report 19664019 ↗InjuryDec 30, 2022Adverse 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 VISION WAS AT ADDITION +2 AND .75 CYL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT IS NOT SATISFIED NEAR VISION.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 16076678 ↗MalfunctionOct 14, 2022Crack; Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS CRACKED, NOTICED UPON INSERTION. LENS WAS REMOVED AND REPLACED WITH THE BACKUP LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND INDICATED THAT THAT THE SURGICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT WAS TO REMOVE THE LENS AND REPLACED WITH UNDAMAGED LENS. NO PATIENT HARM WAS REPORTED. PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. DOCTOR¿S PROGNOSIS WAS INDICATED AS ¿NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15605433 ↗MalfunctionSep 28, 2022Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED A SCRATCH ON THE LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THEY FOUND A SCRATCH ON THE IMPLANT AFTER THE LENS WAS INSERTED.
Patient problems: Insufficient Information
MAUDE report 15500974 ↗InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY OF VISION. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 15130533 ↗InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MYOPIC SURPRISE AND WAS NOT HAPPY WITH THE NEAR VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 14787013 ↗InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FACILITY REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS EXCHANGED DUE TO MECHANICAL COMPLICATION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14523237 ↗InjuryNov 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
A CLINIC MANAGER REPORTED THAT APPROXIMATELY TWO MONTHS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 12897124 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.