AcrySof™ IQ Vivity™ DAT315 (REF DAT315.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652427067), received between Jun 1, 2021 and Nov 9, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION, PHOTOSENSITIVITY. THE SURGEON SENT THE PATIENT TO A RETINAL SPECIALIST AND THE RETINAL SPECIALIST SAID HER EYE WAS FINE. THE PATIENT THEN VISITED HER SURGEON AND THE SURGEON INFORMED HER THAT THE LENS WAS TIPPED, RUBBING IRIS CAUSED THE ISSUE. THE PATIENT WAS TOLD SHE WAS HAVING WEAK ZONULES. THE PATIENT HAD MULTIPLE SECOND OPINIONS AND FINALLY FOUND A SURGEON WHO WILL EXPLANT THE LENS AND REPLACE IT WITH A MONOFOCAL LENS. THE LENS EXPLANT AND REPLACED WAS PLANNED ON WEDNESDAY (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18099447 ↗
• InjurySep 8, 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 BLURRINESS AND WAS NOT ABLE TO TOLERATE TO THE LENS, THEREFORE THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15376972 ↗
• InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLUR AND THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15368132 ↗
• MalfunctionJun 24, 2022Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS NOTICED WITH SCRATCHED AND REMOVED FROM THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14799577 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PURCHASING MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED POOR VISUAL ACUITY. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 5 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14187679 ↗
• InjuryJul 27, 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 UNABLE TO READ OR SEE INTERMEDIATE WITH THE IOL. THE IOL WAS EXCHANGED FOR ANOTHER LENS AFTER 15 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS ¿NEAR VISION 16, NO INTERMEDIATE¿. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 12234720 ↗
• InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED DOUBLE VISION FOLLOWING INTRAOCULAR LENS IMPLANTATION PROCEDURES OF BOTH EYES. IT WAS NOTED THAT DOUBLE VISION AT READING AND COMPUTER DISTANCE; "ONE IMAGE RELATIVELY CLEAR, AND ANOTHER LIGHTER IMAGE OVERLAPPING AND SLIGHTLY OFFSET, MAKING IT IMPOSSIBLE TO DISCERN WHAT IS WRITTEN. DISTANCE IS EFFECTED AS WELL BUT LESS IMPACTFUL - MARGINAL." ADDITIONAL INFORMATION REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12218946 ↗
• InjuryJun 1, 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) IMPLANTATION PROCEDURE, THE PATIENT WAS NOT HAPPY WITH THE VISUAL OUTCOME. THE IOL WAS EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 11913861 ↗