AcrySof™ IQ Vivity™ DAT315 (REF DAT315.195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652427081), received between May 24, 2021 and Apr 18, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON FOR EXPLANT WAS REPORTED AS REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) LENS MODEL 28 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19135692 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED POOR NEUROADAPTATION FROM FLARE AND HALOS FROM IOL. THE IOL WAS EXCHANGED WITH ANOTHER IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15042715 ↗
• InjuryJul 6, 2022Adverse 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 POOR VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 8 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14927191 ↗
• InjuryMar 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED SIGNIFICANT MYOPIC RESULTS AND PATIENT ALSO HAD YTTRIUM ALUMINUM GARNET CAPSULOTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 13854595 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, IT WAS NOTED THAT THE INSUFFICIENT IOL POWER WAS IMPLANTED. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 13493972 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A OPHTHALMIC SURGEON REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED WAXY VISION AND INABILITY TO SEE AT NEAR AT ALL WITHOUT CORRECTION. THE EXPLANT OF THE LENS WAS PLANNED BY SURGEON. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12764085 ↗
• InjuryOct 26, 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 EXPERIENCED POOR VISION AT ALL RANGES AND POOR ADAPTATION TO IOL. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE SYMPTOMS WERE RESOLVED TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, IN THE SURGEONS OPINION THE POOR ADAPTATION TO THE IOL CAUSED THE EVENT.

  Patient problems: Visual Disturbances

  MAUDE report 12696560 ↗
• InjuryOct 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISCOMFORT AND WAS UNABLE TO TOLERATE THE LENS. THE IOL WAS REPLACED WITH AN ALTERNATE IOL 56 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 12617352 ↗
• InjuryMay 24, 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 A MONTH AFTER IMPLANTATION DUE TO SUBJECTIVE VISUAL DISTURBANCE AND IOL HAS TOO MUCH ASTIGMATISM CORRECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 11869867 ↗