AcrySof™ IQ Vivity™ DAT015 (REF DAT015.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00380652424677), received between Mar 18, 2021 and Sep 12, 2024 — classified as 23 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 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 RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20199793 ↗
• InjuryApr 1, 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 SUBJECTIVE VISUAL DISTURBANCE. THE IOL WAS EXCHANGED FOR ANOTHER UNSPECIFIED LENS MODEL APPROXIMATELY 8 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXCHANGE WAS SUBJECTIVE VISUAL DISTURBANCE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT WAS NOT ADJUSTING TO OPTIC OF IOL AND INABILITY TO ADAPT.

  Patient problems: Visual Impairment

  MAUDE report 19012530 ↗
• InjuryJan 12, 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 IS NOT SATISFIED WITH DISTANCE VISION AND PATIENT WAS UNABLE TO ADAPT TO THE TECHNOLOGY OF LENS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 18502083 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT DID NOT ADAPT TO THE LENS AND SAW DIAGONAL LINES. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances

  MAUDE report 17905099 ↗
• MalfunctionOct 4, 2023Defective Component; Defective Component

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT WHEN TRYING TO LOAD THE LENS IN THE INJECTOR THE HAPTIC ON THE LENS WOULD NOT CURL AND WAS UNABLE TO BE LOADED CORRECTLY IN PREPARATION. THERE WAS NO PATIENT CONTACT WITH THE PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 17866993 ↗
• MalfunctionApr 25, 2023Crack; Crack

  AN OPHTHALMIC SURGEON REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND TO BE CRACKED. HENCE THE LENS WAS REMOVED DURING THE PROCEDURE AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16808111 ↗
• InjuryApr 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DIFFICULTY SEEING TO DRIVE. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MISSED TARGET, -0.75 RESIDUAL CORRECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16759901 ↗
• InjuryMar 21, 2023Optical Decentration; Optical Decentration

  A MATERIALS MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECENTERED POSTERIOR CAPSULE INTRA OCULAR LENS (PCIOL) AND A DISTORTED VISION. THE IOL WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE FOR MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 16585202 ↗
• InjuryAug 1, 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 DOUBLE VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIA SECONDARY TO MULTIFOCAL. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, AS PER THE SURGEONS OPINION IOL DID NOT CONTRIBUTED THE EVENT AND IT WAS DUE TO MONOCULAR DOUBLING AND SHADOWING. NO PATIENT HARM WAS REPORTED.

  Patient problems: Visual Impairment

  MAUDE report 15137405 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS SLIGHTLY UNHAPPY WITH THE VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS "SLIGHTLY MYOPIC". ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT, THERE IS NO PATIENT HARM INVOLVED. THE PATIENT WAS NOT HOSPITALIZED.

  Patient problems: Visual Disturbances

  MAUDE report 14683269 ↗
• InjuryApr 26, 2022Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STATES THAT, SHE FELT ISSUE WITH THE LENS (UNSPECIFIED) AS IT WAS NOT PERFORMING AS EXPECTED. THE PATIENT DEPTH OF PERCEPTION IS OFF, SHE IS UNABLE TO DRIVE COMFORTABLY. THE PATIENT HAS A SWEET SPOT AT ABOUT THREE FEET THAT SHE CAN SEE CLEARLY. THE PATIENT HAS A DARK SHADOW PERIPHERALLY (HALF MOON), THAT SHE FELT IT IS GETTING LARGER. THE PATIENT HAS SEEN A RETINAL SPECIALIST AND WAS TOLD EVERYTHING WAS FINE BUT DID HAVE MILD MACULAR DEGENERATION. THE PATIENT PHYSICIAN STATED, SHE NEEDS TO HAVE YTTRIUM ALUMINUM GARNET (YAG) BUT ONCE THAT IS DONE WOULD NOT BE ABLE TO HAVE ANY ADDITIONAL PROCEDURES. THE PATIENT¿S DOCTOR ALSO PERFORMED "BAG" PROCEDURE WITH A MEMBRANE THAT WAS PLACED ON HER CORNEA TO HELP HEALING, AFTER THE SURGERY IN HER LEFT EYE SHE HAD TO HAVE "TAP" DUE TO INCREASE PRESSURE. THE PATIENT USED ADDITIONAL DROPS THAT SAMPLES WERE PROVIDED TO HELP WITH INTRAOCULAR PRESSURE (IOP). THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT, THIS REPORT IS FOR LEFT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Disturbances

  MAUDE report 14204557 ↗
• InjuryApr 26, 2022Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STATES SHE FEELS UNSPECIFIED LENS ISSUE AS IT WAS NOT PERFORMING AS EXPECTED. HER DEPTH PERCEPTION IS OFF, SHE IS UNABLE TO DRIVE COMFORTABLY. SHE HAS A "SWEET" SPOT AT ABOUT THREE FEET THAT SHE CAN SEE CLEARLY. HAS SEEN A RETINAL SPECIALIST AND WAS TOLD EVERYTHING WAS FINE BUT DID HAVE MILD MACULAR DEGENERATION. HER PHYSICIAN STATED SHE NEEDS TO HAVE YAG BUT ONCE THAT IS DONE WOULD NOT BE ABLE TO HAVE ANY ADDITIONAL PROCEDURES. HER DOCTOR ALSO PERFORMED "BAG" PROCEDURE WITH A MEMBRANE THAT WAS PLACED ON HER CORNEA TO HELP HEALING. AFTER SURGERY IN HER LEFT EYE SHE HAD TO HAVE "TAP" DUE TO INCREASE PRESSURE. USED ADDITIONAL DROPS THAT SAMPLES WERE PROVIDED TO HELP WITH INTRAOCULAR PRESSURE (IOP). THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Disturbances

  MAUDE report 14204183 ↗
• InjuryApr 13, 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 GLARE AND DECREASED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PATIENT WAS DISSATISFIED WITH THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14103050 ↗
• MalfunctionMar 25, 2022Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS TORE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904805 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A ACCOUNT MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT REPORTED DIFFICULTY SEEING HER FAMILY MEMBER'S FACES AND CANNOT SEE HER GRANDCHILDREN'S FACES AT THE SCHOOL PROGRAMS. SHE WAS NOT HAPPY WITH HER VISION AT NIGHT AND UNABLE TO DRIVE DUE TO THE GLARE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 13620525 ↗
• InjuryFeb 24, 2022Adverse 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. THE PATIENT INFORMED THIS TO HIS OPERATING PHYSICIAN (OP). THE PHYSICIAN KEPT SAYING THAT, IT WAS DRY EYE, BUT THE EYE DROPS DIDN'T HELP AT ALL. BEFORE THE SURGERY, THE PATIENT NEEDED CHEATER TO SEE, HOWEVER NOW THE PATIENT CAN'T SEE THE BIG SIGNS ON THE ROAD. ADDITIONAL INFORMATION RECEIVED AND STATED THAT HAVING TROUBLE IN DISTANCE VISION IN RIGHT EYE, READING IS STILL DIFFICULT, AND THERE IS A NEED FOR GLASSES, STILL SUFFERING FROM DRY EYES.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Impairment

  MAUDE report 13596507 ↗
• InjuryFeb 17, 2022Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS AGAIN EXCHANGED IN A SECONDARY PROCEDURE DUE TO INCORRECT LENS POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13549665 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE CLINICAL REASON WAS REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13026600 ↗
• MalfunctionOct 6, 2021Scratched Material; Scratched Material

  AN ACCOUNT MANAGER REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS NOTICED THAT THE LENS HAD A LINE/MARK THAT WAS NOT CAUSED BY FORCEPS DURING THE LOADING PROCESS. THEN LENS WAS CUT OUT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584602 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON HAS REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINS OF POOR DISTANCE VISION. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON THAT APPROXIMATELY ONE MONTH FOLLOWING HER CATARACT EXTRACTION WITH IOL IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED SLIGHT INFLAMMATION AND LIGHT SENSITIVITY. HER POSTOPERATIVE STEROID DROP WAS INCREASED. THE SURGEON FELT THAT THE VISION WAS REDUCED DUE TO DRYNESS. THE PATIENT WAS GIVEN ARTIFICIAL TEARS AND AN ANTI-INFLAMMATORY TOPICAL MEDICATION. THE PATIENT RETURNED 6 WEEKS FOLLOWING THE PROCEDURE, COMPLAINING OF DOUBLE VISION, PAIN, AND POOR VISION. THIS IS GRADUALLY WORSENING. THE SYMPTOMS SEEM TO BE WORSE IN THE SUNSHINE. THESE PROBLEMS HAVE BEEN FAIRLY STABLE SINCE THE ONSET AND HAVE BEEN PERSISTENT. SHE ALSO REPORTS PAIN IN HER FACE AND AROUND HER EYES/CHEEK AREAS WHICH BECOME WORSE BY THE END OF THE DAY. THE VISION IS STILL VERY BLURRY FAR AWAY, BUT OKAY AT NEAR/INTERMEDIATE. SHE IS UNABLE TO READ STREET SIGNS AND FEELS UNSAFE TO DRIVE AT THE MOMENT. THE PATIENT HAS A HISTORY OF POSTOPERATIVE IRITIS WHICH IS IMPROVING. POSTERIOR CAPSULE OPACIFICATION WAS NOTED ON EXAMI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dry Eye(s); Eye Pain; Inflammation; Iritis; Visual Disturbances; Visual Impairment

  MAUDE report 12479743 ↗
• MalfunctionSep 8, 2021Contamination; Contamination

  A FACILITY REPRESENTATIVE REPORTED AN INTRAOCULAR LENS (IOL) WITH A DESCRIPTION OF SOMETHING INSIDE THE IOL. THE LENS WAS PLACED IN THE EYE AND NOTICED SOMETHING ABNORMAL INSIDE THE LENS. THE SURGEON RINSED THE EYE WITHOUT REMOVAL OF OBJECT AND THEN REMOVED THE LENS FROM THE PATIENT'S EYE. PROCEDURE WAS COMPLETED THE SAME DAY WITH A NEW LENS. THE SURGEON FELT AS IF THE LENS HAD A FOREIGN OBJECT IN IT AND DID CAUSE THE EVENT TO OCCUR. NO PATIENT HARM WAS REPORTED AND NO ISSUES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12438330 ↗
• InjurySep 7, 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¿S VISION WAS DECREASED. THE IOL WAS EXCHANGED FOR ANOTHER LENS IN A SECONDARY PROCEDURE 105 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 12435211 ↗
• InjurySep 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED DECREASED VISION. THE IOL WAS REPLACED WITH ANOTHER LENS 79 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12428004 ↗
• InjuryAug 22, 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 (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH DISTANCE VISUAL ACUITY. THE IOL WAS REPLACED WITH ANOTHER IOL. THE CLINICAL REASON FOR EXPLANT WAS GIVEN AS RESIDUAL MIXTURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12352004 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED VIA EMAIL, THAT CONSUMER EXPERIENCED BLURRY VISION AND INTOLERANCE TO TECHNOLOGY, THAT LEAD TO THE EXPLANTATION OF THE INTRAOCULAR LENS. ADDITIONAL INFO HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION OBTAINED.

  Patient problems: Blurred Vision

  MAUDE report 12024661 ↗