AcrySof™ IQ Vivity™ DAT415 (REF DAT415.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652427913), received between Oct 5, 2021 and May 31, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Malposition of 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 31, 2023Malposition of Device; Malposition of Device

  THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Capsular Bag Tear

  MAUDE report 17029098 ↗
• InjuryFeb 23, 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 LEFT EYE.

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

  MAUDE report 16425899 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REGISTERED NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS CYSTOID MACULAR EDEMA (CME) FOLLOWING INITIAL CATARACT SURGERY, RESIDUAL AND VISION DID NOT CLEAR ENOUGH. ADDITIONAL INFORMATION WAS RECEIVED STATING BLURRED VISION CONTINUES AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Blurred Vision; Macular Edema

  MAUDE report 15915253 ↗
• 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 FOR LEFT 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 15841692 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED HALOS HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 15594462 ↗
• InjuryApr 25, 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, HALOS, MYOPIC VISION AND BCVA 20/30 UNEXPLAINABLE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 14192302 ↗
• InjuryOct 5, 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 BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS FOUR MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12577117 ↗