AcrySof™ IQ Vivity™ DAT315 (REF DAT315.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652427135), received between Apr 28, 2021 and Nov 25, 2025 — classified as 10 injuries, 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse 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 AND CLINICAL REASON FOR EXPLANT BEING MYOPIA. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 23647011 ↗
• InjurySep 26, 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 PATIENT EXPERIENCED BLURRED UNCORRECTED VISION AND LARGE REFRACTIVE SURPRISE. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE WITH A MONO FOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15485575 ↗
• InjurySep 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED BLURRY FUZZY EDGES. THE PATIENT CANNOT READ A TV SCREEN. EVEN LARGE SCREEN TVS HAVE LIKE THE WEATHER REPORT EVEN 8 TO 10 FOOT AWAY. EVERYTHING HAS A SLIGHT SHADOW JUST ABOVE IT. . LETTERS HAVE A GHOST SHADOW JUST ABOVE THEM. THE BIGGEST PROBLEM THE PATIENT FACING IS THE DYSPHOTOPSIA. ALL LIGHTS ESPECIALLY IN THE DISTANCE, GREATER THAN READING DISTANCE, HAVE STARBURSTS, GLARE, BRILLIANCE, SPARKLE, ETC, HENCE CAN'T READ INFO FROM LIGHT. ADDITIONAL INFORMATION RECEIVED AND STATED FROM THE BEGINNING EVERYTHING IS STILL BLURRY AND OUT OF FOCUS. THE EDGES OF ANYTHING ARE NOT SHARP AND THE CONTRAST IS POOR. EYES ARE VERY OFTEN SORE, BURNING AND STINGING, SOMETIME SCRATCHY FEELING. ONE EVENING AFTER WORKING IN SHOP REALLY STRAINING TO SEE, VISION JUST WENT GREY SHADOWY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Excessive Tear Production; Eye Pain; Irritability; Visual Disturbances

  MAUDE report 15443375 ↗
• InjuryMay 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED LOT OF INFLAMMATION FOR WHICH SHE WAS USING STEROIDS. THE ISSUE IS RESOLVING. THE PROBLEM SHE MOST STRUGGLES WITH IS DISTANCE VISION. SHE DESCRIBES, "IT IS LIKE LOOKING THROUGH A CAR WINDSHIELD WITH ICE ON IT. MID AND NEAR VISION IS GOOD, BUT DISTANCE IS NOT GOOD. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AS THE REPORTER IS UNWILLING TO FOLLOW-UP.

  Patient problems: Blurred Vision; Halo; Inflammation; Visual Disturbances

  MAUDE report 14467162 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE POOR DISTANCE VISION. THE LENS WAS EXCHANGED WITH A NON-COMPANY LENS IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT SYMPTOMS WERE RESOLVED AFTER THE EXPLANT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 14073569 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED POOR VISION/QUALITY AND ENDED WITH MYOPIC SURPRISE. THE LENS WAS EXPLANTED IN SECONDARY PROCEDURE WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13582948 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED DUE TO A RESIDUAL CYLINDER GREATER THAN 1.25D AND POOR ASTIGMATISM CORRECTION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE TWO WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE.  ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 13334492 ↗
• MalfunctionNov 8, 2021Break; Break

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED UPON INSERTION AND IT HAD TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770823 ↗
• InjuryOct 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN HAS REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS POST-OP REFRACTIVE SURPRISE EXPERIENCED BY THE PATIENT. ADDITIONAL INFORMATION RECEIVED BY THE FACILITY REPRESENTATIVE THAT, THE IOL WAS EXCHANGED WITH ANOTHER LENS APPROXIMATELY AFTER 10 MONTHS FOLLOWING THE INITIAL IMPLANT.

  Patient problems: Visual Impairment

  MAUDE report 12600530 ↗
• MalfunctionSep 29, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED VIA A RETURN FORM THAT THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546872 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT INTRAOCULAR LENS WAS EXPLANTED DUE TO FOGGY AND BLURRY VISION AT ALL DISTANCES. ADDITIONAL INFO HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 12110368 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED 2 WEEKS AFTER IMPLANTATION DUE TO REFRACTIVE SURPRISE. THE REPLACEMENT LENS INFORMATION IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 11737135 ↗