AcrySof™ IQ Vivity™ DAT015 (REF DAT015.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380652424646), received between Mar 8, 2021 and Feb 24, 2025 — classified as 15 injuries.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Adverse 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 EXPERIENCED VISUAL DISTURBANCES. CLINICAL REASON BEING MENTIONED AS INCONSISTENT AXIS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN NON COMPANY MONOFOCAL LENS IN THE SECONDARY IMPLANT PROCEDURE. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21444617 ↗
• InjuryJan 10, 2025Adverse 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 WITH BLURRY VISION FROM DISTANCE AND NEAR AND POOR QUALITY OF VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 24 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS VISUAL ACUITY NOT CORRECTING PAST 20/40. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21122662 ↗
• 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 20198498 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT HAD DISTORTED VISION AND WAS UNABLE TO SEE. PATIENT WAS UNHAPPY WITH THE OUTCOME. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, IMPLANTATION WAS DONE IN PATIENT'S RIGHT EYE. THE PATIENT CLAIMED THAT IT APPEARED TO BE LOOKING OUT OF DIRTY CONTACT. IOL EXCHANGE WAS DONE WITH ANOTHER NON-COMPANY LENS. IN THE SURGEON OPINION THE ISSUE WAS NOT DUE TO THE PRODUCT (IOL).

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17660725 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHE WAS NOT ABLE TO SEE WELL AT DISTANCE, ALSO STATES SHE CANNOT SEE WELL ENOUGH TO DRIVE AT NIGHT, AND IS EXTREMELY PHOTOPHOBIC ALSO HAD TO CHANGE OUT LIGHTS IN HOUSE AND APPLIANCES FOR SOFTER BRIGHTNESS LEVELS IN ORDER TO FUNCTION AND TOLERATE THE LIGHT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH RIGHT EYE. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Dizziness; Dry Eye(s); Eye Pain; Headache; Inflammation; Itching Sensation; Visual Disturbances; Visual Impairment

  MAUDE report 15841694 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER STATED THAT THERE WAS NO CHANGE IN HER EYES STILL WEARING GLASSES AND DID NOT IMPROVE HER VISION. ADDITIONAL INFORMATION WAS RECEIVED AND SHE WAS UNABLE TO READ WITHOUT GLASSES, SHE REALLY STRUGGLES TO SEE THE LETTERS. THE PATIENT WAS NOT ABLE TO DRIVE AT NIGHT. AT NIGHT SHE SEES A GRAY BLUR IN HER VISION. SHE WAS EXPECTING 20/20 VISION. SHE HAS HAD LASER TREATMENTS AND STILL NO IMPROVEMENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15689718 ↗
• InjuryOct 10, 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 NOT HAPPY WITH THE QUALITY OF VISUAL ACUITY, NOT HAPPY WITH THE ABILITY TO DRIVE, WATCH TV OR READ AND THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE, CLINICAL REASON FOR THE EXPLANT WAS REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15568863 ↗
• InjuryAug 11, 2022Adverse 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 DISTANCE VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MYOPIC TARGET MISS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15210542 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS EXTREMELY NEARSIGHTED. SHE ALSO HAD DEVELOPED INFLAMMATION AND SWELLING IN THE EYE AND MACULAR DEGENERATION. ADDITIONAL INFORMATION WAS RECEIVED THAT, HER MILD MACULAR DEGENERATION GOT WORSE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR LEFT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Inflammation; Swelling/ Edema

  MAUDE report 14021324 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 13521336 ↗
• InjuryJan 3, 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 IOL WAS EXCHANGED WITH AN ALTERNATE IOL 40 DAYS FOLLOWING THE INITIAL PROCEDURE. SUBJECTIVE VISUAL DISTURBANCE WAS THE CLINICAL REASON MENTIONED FOR EXPLANT. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13142204 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO VISION BLURRY, THE PATIENT WAS SEEING BETTER WITH OLD GLASSES. THE IOL WAS EXCHANGED FOR A DIFFERENT IOL APPROXIMATELY AFTER 15 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 12369211 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED EXPLANTATION OF AN INTRAOCULAR LENS (IOL) WITH A CLINICAL REASON OF "NON ADAPTIVE TO NEAR POWER EXCHANGE".

  Patient problems: Visual Impairment

  MAUDE report 11697317 ↗
• InjuryApr 7, 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 COULD NOT SEE ANYTHING WELL AT DISTANCE OR NEAR. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 11631149 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT HAD DIFFICULTY ADJUSTING TO DEPTH OF FOCUS LENS AND WAS NOT HAPPY WITH THE VISION. LENS WAS EXCHANGED IN THE SECONDARY PROCEDURE WITH A NON COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11435375 ↗