AcrySof™ IQ Vivity™ DAT015 (REF DAT015.185)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380652424608), received between Jun 3, 2021 and Sep 12, 2024 — classified as 11 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (3 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 Problem9
- Scratched Material3
- Appropriate Device Problem Term/Code Not Available2
- Defective Device1
Patient problems
- Blurred Vision6
- Visual Impairment5
- Insufficient Information3
- Visual Disturbances2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Eye Pain1
- No Clinical Signs, Symptoms or Conditions1
- Posterior Capsule Opacification1
Recent adverse event reports
The 15 most recent of 15 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 20201388 ↗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 RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 20201258 ↗InjuryFeb 13, 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 BLURRY VISION, DIFFICULTIES FOCUSING. CLINICAL REASON BEING THE SAME. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXCHANGED FOR A NON COMPANY LENS. LENS EXPLANTED BECAUSE THE PATIENT'S VISION WAS IRRECONCILABLY BLURRED WITH ASSOCIATED INABILITY TO FOCUS VISION, ATTRIBUTED TO THE VIVITY EXTENDED DEPTH OF FOCUS LENS. SYMPTOMS IMPROVED. PCO (POSTERIOR CAPSULAR OPACIFICATION) HAS BEEN OBSERVED. THIS FILE BELONGS TO THE RIGHT EYE.
Patient problems: Blurred Vision; Posterior Capsule Opacification; Visual Impairment
MAUDE report 18694872 ↗InjuryFeb 1, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON WAS UNHAPPY WITH DISTRACTION AND CLARITY. CLINICAL REASON BEING UNHAPPY UNABLE TO TOLERATE GLASSES OR CONTACTS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE IOL WAS EXCHANGED FOR A NON COMPANY LENS. SYMPTOMS RESOLVED.
Patient problems: Insufficient Information
MAUDE report 18622335 ↗InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION AT ALL DISTANCES DESPITE GOOD REFRACTIVE OUTCOME. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT IS PATIENT IS UNHAPPY AND UNSATISFIED WITH VISION POST SURGERY. ADDITIONAL INFORMATION RECEIVED AND STATED, THE PATIENT UNABLE TO SEE WELL WITH THE IMPLANT. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: Blurred Vision
MAUDE report 16806065 ↗InjuryMar 17, 2023Adverse 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, THE PATIENT UNHAPPY WITH VISION ACUITY. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 6 WEEK OF INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 16563038 ↗MalfunctionJan 20, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT LENS HAD A SCRATCH AT PERIPHERAL OPTIC. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16214698 ↗InjuryNov 11, 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 POOR VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS MINOR MACULOPATHY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 15779615 ↗InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NEAR SIGHTED AND BLURRY VISION. THE PATIENT COULD NOT READ USING ONLY RIGHT EYE. THE PROVIDED GAVE A PRESCRIPTION FOR MULTIFOCAL GLASSES AND EVEN GLASSES DID NOT WORK. THE PATIENT HAD EMERGENCY SURGERY, WHERE A VITRECTOMY WAS PERFORMED. IT WAS STATED THAT, THE GAS BUBBLE IS CAUSING LOSS OF VISION. THE PATIENT TRIED TO CONTINUE BUT AFTER A FEW HOURS OF CLOSE MONITOR WORK, PATIENT COULD EXPERIENCE THE PAIN. THEN PATIENT GONE WITH THE YTTRIUM ALUMINUM GARNET (YAG) AND EXPERIENCED DETACHED RETINA.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Eye Pain; Retinal Detachment; Visual Disturbances
MAUDE report 15002138 ↗MalfunctionJun 16, 2022Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTED THE LENS HAD A SCRATCH AFTER IMPLANTING, SO HE CRACKED IT IN HALF, REMOVED IT, AND INSERTED A NEW LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14715779 ↗MalfunctionJun 9, 2022Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT A SCRATCH LENS WAS NOTICED AFTER IMPLANTATION. THE LENS WAS EXCHANGED DURING AN INITIAL PROCEDURE. HOWEVER THE EYESIGHT IS NO BETTER THAN BEFORE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 14643989 ↗InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE CONSUMER EXPERIENCED POOR DISTANCE, CANT SEE WELL BEYOND 8 FEET. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 14468787 ↗InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AN ADMINISTRATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION, LENS FAILURE AND UNEXPECTED MYOPIA POST-OP. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 13772758 ↗MalfunctionOct 20, 2021Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED A LENS WAS FOUND OUT TO BE DEFECTIVE. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12665760 ↗InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED VISUAL DISTURBANCES, VISION OUT OF FOCUS AND SEEING SHADOWS AROUND THE LETTERS. POST IMPLANTATION OF APPROXIMATELY THREE MONTHS THE LENS WAS EXCHANGED FOR A MONOFOCAL LENS. THE SYMPTOMS WERE RESOLVED.
Patient problems: Visual Disturbances
MAUDE report 11929672 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
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- 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.