AcrySof™ IQ Vivity™ DAT015 (REF DAT015.225)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00380652424684), received between Apr 12, 2021 and Sep 12, 2024 — classified as 11 injuries, 5 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 Problem11
- Scratched Material4
- Defective Device1
Patient problems
- Blurred Vision7
- Insufficient Information5
- Visual Disturbances4
- Visual Impairment4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Corneal Edema2
- Anxiety1
- Chemosis1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjurySep 12, 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 HAD MALADAPTATION. THE IOL WAS EXCHANGED, FOR UNSPECIFIED LENS MODEL AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 20206839 ↗InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE ANOTHER LENS MODEL BUT ONE DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.
Patient problems: Blurred Vision
MAUDE report 20157425 ↗InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED NEGATIVE, DYSPHOTOPSIA, POOR VISION QUALITY. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS, PERIPHERAL SHADOW IN VISION AND POOR VISION WITH GLASSES AND CONTACTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 19476120 ↗MalfunctionMar 4, 2024Scratched Material; Scratched Material
THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18824917 ↗MalfunctionDec 19, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18354209 ↗InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED INTOLERABLE HALOS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. THE CLINICAL REASON FOR EXPLANT WAS TRIED PUPIL CONSTRICTION, CONTACT LENS, TIME TO ADJUST AND THE PATIENT WAS UNHAPPY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo
MAUDE report 16619459 ↗InjuryOct 3, 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 EXPERIENCED DECREASED VISION POST POSTOPERATIVELY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT PATIENT EXPERIENCED CONJUNCTIVAL CHEMOSIS, EDEMA AND PERSISTENT INFLAMMATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STEROIDS. THE PATIENT ALSO EXPERIENCED STRAINING AND LETTERS LOOKS GREY INSTEAD OF BLACK. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Blurred Vision; Chemosis; Corneal Edema; Eye Pain; Inflammation; Visual Disturbances
MAUDE report 15527878 ↗InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED DECREASED BCVA (BEST CORRECTED VISUAL ACUITY), DIZZINESS, NAUSEA ON AND OFF, THE VISION WAS WORSE THAN BEFORE SURGERY, DECREASED VISION, BLURRY VISON AN NO DEPTH PERCEPTION. THE PATIENT FEELS ANXIOUS, PRESSURE INCREASED, LOST APPETITE AND WEIGHT. THE PATENT HAS BLOOD SHOT EYE. VA WAS LIMITED BY INFLAMMATION AND EDEMA, TREATED WITH ANTIBIOTIC AND STEROIDS. THE PATIENT EXPERIENCED DESCEMENT FOLD, CORNEAL OPACITY LINEAR.
Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Clouding/Hazing; Corneal Edema; Decreased Appetite; Dizziness; Nausea; Red Eye(s); Visual Impairment
MAUDE report 15504378 ↗MalfunctionMay 27, 2022Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH WAS NOTED ON IOL. THE SURGEON REPLACED WITH THE NEW LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14522222 ↗InjuryMar 24, 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, LENS WAS EXPLANTED, DID NOT SPECIFY THE REASON. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13891251 ↗InjuryMar 23, 2022Adverse 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 BLURRED VISION AND UNABLE TO ADOPT THE IOL. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM REPORTED.
Patient problems: Blurred Vision
MAUDE report 13856918 ↗InjuryDec 15, 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 EXPERIENCED IRIDODONESIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT PATIENT EXPERIENCING NEGATIVE DYSPHOTOPSIA AND IRIDODONESIS WHICH ARE EXTREMELY BOTHERSOME. BOTH SYMPTOMS STARTED IMMEDIATELY AFTER SURGERY. A DARK SPOT WAS OBSERVED IN PERIPHERAL VISION AND A SHAKING WHEN PATIENT MOVES EYE. PATIENT WAS WORKING FROM HOME BECAUSE BRIGHT LIGHTS EXACERBATE THE SYMPTOMS. THE PATIENT POSTPONED THE RIGHT EYE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT SURGEON TRIED CONSTRICTING PUPIL WITH ALPHAGAN TO HELP WITH DYSPHOTOPSIAS WITHOUT SIGNIFICANT IMPROVEMENT. THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances; Visual Impairment; Vitreous Floaters
MAUDE report 13010166 ↗MalfunctionOct 26, 2021Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRA OCULAR LENS (IOL) IMPLANT PROCEDURE. THE SURGEON OBSERVED DEFECT ON LENS WHICH WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12696459 ↗InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS IMPLANTATION (IOL), THE PATIENT HAD BLURRY VISION AT ALL DISTANCES. THE LENS WAS EXPLANTED 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS "MILD REFRACTIVE ERROR, DOES NOT SEEM SIGNIFICANT ENOUGH TO EXPLAIN, SUBJECTIVE POOR VISION." ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT THAT, HE SAW A CENTRAL DARK RING ¿LIKE A CHEERIO¿ WHEN LOOKING THROUGH THE IOL. THIS SYMPTOM WAS RESOLVED ONCE THE LENS WAS REMOVED AND REPLACED WITH THE MONOFOCAL IOL.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 12577777 ↗InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT A LENS WAS EXPLANTED DUE TO POOR VISUAL QUALITY. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Blurred Vision
MAUDE report 12330186 ↗MalfunctionApr 12, 2021Scratched Material; Scratched Material
AN INTRAOCULAR LENS (IOL) REPLY CARD WAS RECEIVED FROM A CUSTOMER STATING THAT DURING AN IOL IMPLANT PROCEDURE, THE LENS HAD A SCRATCH, NOT IMPLANTED. THERE WAS NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 11649263 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.