AcrySof™ IQ Vivity™ DAT415 (REF DAT415.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652427937), received between Jun 23, 2021 and Nov 6, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN POST COMPANY LENS VITRECTOMY TO REMOVE FLOATERS IN RIGHT EYE, THERE WAS A MALL OBSTRUCTION IN PATIENT LINE OF VISION. FOLLOWING VARIOUS TESTS, INCLUDING LINE OF VISION AND EVEN AN MRI, THE RETINA AND OPTIC NERVES WERE NORMAL. YET, THE OBSTRUCTION WAS THERE AND MOVES WITH LINE OF SIGHT. BY DEDUCTION, THE LENS MIGHT BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THERE WAS AN OBSTRUCTION WITH LINE OF SIGHT OF THE RIGHT EYE THAT MOVES WITH EYE MOVEMENT. THE OBSTRUCTION APPEARS TO BE DIAGONALLY RUNNING BETWEEN 8 AND 6 O'CLOCK (FOR BETTER DESCRIPTION), ABOUT A MILLIMETER IN WIDTH AND 3-4 MM IN LENGTH, SHAPED LIKE A BEAN, AND OF LIGHT GRAY COLOR. IT MOVES UP, DOWN, LEFT AND RIGHT WITH DIRECTION OF SIGHT. ENDED UP PERFORMING A SECOND VITRECTOMY ON THE ASSUMPTION THAT THE OBSTRUCTION MIGHT BE A REMENANCE OF A FLOATER. WHICH WAS AN ADDITIONAL LAYER OF REPEATED EMOTIONAL DISTRESS (GIVEN THAT MY WORK NECESSITIES RESEARCH, READING, COMPUTERS, AND TYPING), LITERALLY INEFFECTIVE, FOR, THE OBSTRUCTION REMAINS THE SAME.

  Patient problems: Visual Impairment; Vitreous Floaters

  MAUDE report 20618391 ↗
• InjuryNov 11, 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 HAD POOR VISUAL ACUITY. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL, 14 DAYS FOLLOWING THE INITIAL PROCEDURE. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Blurred Vision

  MAUDE report 12797374 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT INTRAOCULAR LENS WAS EXPLANTED DUE TO DISSATISFACTION WITH VISUAL OUTCOME AND CLINICAL REASON OF REFRACTIVE SURPRISE. ADDITIONAL INFO WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12048238 ↗