AcrySof™ IQ Vivity™ DAT315 (REF DAT315.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652427098), received between Sep 22, 2021 and May 2, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Defective Device” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED FAINT SECONDARY IMAGE IN EACH EYE. WHEN LOOKING AT A SIGN WITH LIGHT LETTERS ON A DARK BACKGROUND, THE IMAGE IS TO THE LEFT. WHEN LOOKING AT A DARK IMAGE ON A LIGHT BACKGROUND, THE IMAGE IS TO THE RIGHT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT A WRINKLE ON THE CORNEA WAS OBSERVED FOR WHICH DROPS WERE USED TO RULE OUT ANY DEFECT OF THE LENS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD EXPERIENCED HEADACHE, EYE PAIN AND DRY EYE SYNDROME POST SURGERY. THE FAIT SECONDARY IMAGE WAS CLARIFIED TO BE MONOCULAR DOUBLE VISION. IBUPROFEN WAS USED FOR EYE PAIN AND HEADACHE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.

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

  MAUDE report 16855228 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD COMPLICATIONS A WEEK AFTER THE FIRST WEEK, AND WAS DIAGNOSED AS AN INFECTION IN THE EYE. THE SYMPTOMS THAT THE PATIENT HAD EXPERIENCED WAS CONSTANT DRY EYE AND SEEING RINGS ON LIGHT AT NIGHT. THE PATIENT WAS UNABLE TO SEE ANYTHING UNLESS IN VERY BRIGHT LIGHTS ALL THE TIME. THE LETTERS CONTINUE TO BE MORE FUZZY AND HARDLY HAD A TIME WHERE THE LETTERS WERE CLEAR AND CRISP REGARDLESS OF THE DISTANCE OF THE WORDS. THE PATIENT WAS CONSTANTLY HAVING VISION CHANGES EVERY 6 MONTHS. THE PHYSICIAN THINKS THAT THE VISION WAS GOOD AND WAS 20/20 BUT THE LETTERS WERE NOT CRISP. THE PATIENT WAS DIAGNOSED WITH GUTTATA BASED ON THE CELL COUNT OF EYES. NINE MONTHS POST-OP YAG WAS PERFORMED. WHICH HELPED ONLY FOR A SHORT TIME. THE REPORTER ADDED THE RINGS AT NIGHT AND INABILITY TO READ IN MEDIUM TO DARKER LIGHTING ARE THE MOST DIFFICULT PARTS ABOUT ALL OF THIS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE RIGHT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dry Mouth; Unspecified Infection; Visual Disturbances; Visual Impairment

  MAUDE report 16458492 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE DISTANCE VISION BEYOND AROUND 18¿ IS STILL FUZZY AS WELL AS CLOSEUP. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING LENS GET DRY DURING AWAKENING HOURS, BUT AFTER USE OF REFRESH ON A REGULAR BASIS WHICH HELPS FOR A WHILE. COMPUTER SCREENS AT ABOUT 31¿ BEGINS TO GET IN THE FUZZY ZONE & THERE ON OUT, MY VISION IS FUZZY AND NOT BEING ABLE TO RECOGNIZE PEOPLE FROM ABOUT 20+ FEET OUT IS SOMEWHAT FRUSTRATING. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING EXPERIENCING LITTLE HAZE 2 MONTHS AGO & SAID IF IT¿S STILL THERE. OPHTHALMOLOGIST CAN FIX IT WITH LASER SURGERY, BUT HE ALSO SAID THAT COULD AFFECT THE VISION PROCESS. THE PATIENT WAIT UNTIL AROUND DECEMBER SINCE RIGHT EYE WAS DONE JUNE 9TH. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Dry Eye(s)

  MAUDE report 15259232 ↗
• InjuryJul 12, 2022Defective Device; Defective Device

  A NURSE REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT FELT LIKE COULD NOT SEE OUT OF THE EYE. THE PHYSICIAN THOUGHT THAT THE LENS MIGHT BE DEFECTIVE. DUE TO IT, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE 2 MONTHS AFTER THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT HAD POOR VISION/BLURRY VISION. THE LENS WAS REPLACED WITH A NON COMPANY LENS.

  Patient problems: Blurred Vision

  MAUDE report 14984680 ↗
• InjuryApr 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED HALOS. THE LENS HAD ROTATED AND THEREFORE IT HAD TO BE REPLACED WITH A SECOND LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SHE DID NOT HAVE LENS EXCHANGED HAD TO HAVE LENS ROTATED DUE TO IT MOVING. THE PATIENT ALSO HAD GLARE AND HALOS BEFORE THE ROTATION OF LENS AND IS STILL HAVING THEM AFTERWARDS SIGNIFICANT ENOUGH TO BOTHER WITH NIGHT DRIVING.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14186360 ↗
• InjuryMar 22, 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 DECREASED VISION DISTANCE AND NEAR VERY BLURRY, REFRACTIVE ERROR, REFRACTIVE KERATOPATHY (RK). THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13853527 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRA OCULAR LENS IMPLANT (IOL) PROCEDURE THE PATIENT EXPERIENCE POOR VISION AND THE LENS WAS LATER EXPLANTED IN A SECONDARY PROCEDURE WITH A CLINICAL REASON OF MYOPIC ENDPOINT AND UNCORRECTED DISTANCE VA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12515563 ↗