AcrySof™ IQ Vivity™ DFT615 (REF DFT615.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652423328), received between May 3, 2023 and May 3, 2023 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT WAS UNSATISFIED. AFTER 4 WEEKS POST-OP, THE PATIENT HAD ALWAYS NAUSEOUS IN THE MORNING, HEADACHE, DIZZINESS OFF AND ON, NOT FOCUSING SHARPLY, FOCUS ALWAYS HAZY, DISTANCE TO INTERMEDIA DISTORTED, SHADOW TO DOUBLE MONOCULAR, SEEMS LIKE WRONG GLASSES. THE PHYSICIAN NOTICE THAT THE ASTIGMATISM WAS SOMEWHAT UNDER CORRECTED WITH THE LENS. THE PATIENT HAD ALSO HAS POST OP THE ORIGINAL AXIS. BUT OTHERWISE PHYSICIAN HAVE NO EXPLANATION FOR THESE PHENOMENA. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT COMPLAINTS ABOUT BLURRED VISION. THE PATIENT'S ISSUES WAS NOT RESOLVED. THE SURGEON PROGNOSIS IS STILL BAD THE PATIENT RECEIVED TOUCH-UP TREATMENT (WITH LASIK).

  Patient problems: Blurred Vision; Dizziness; Headache; Nausea; Visual Disturbances; Visual Impairment

  MAUDE report 16860732 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT WAS UNSATISFIED. AFTER 4 WEEKS POST-OP, THE PATIENT HAD ALWAYS NAUSEOUS IN THE MORNING, HEADACHE, DIZZINESS OFF AND ON, NOT FOCUSING SHARPLY, FOCUS ALWAYS HAZY, DISTANCE TO INTERMEDIA DISTORTED, SHADOW TO DOUBLE MONOCULAR, SEEMS LIKE WRONG GLASSES. THE PHYSICIAN NOTICE THAT THE ASTIGMATISM WAS SOMEWHAT UNDER CORRECTED WITH THE LENS. THE PATIENT HAD ALSO HAS POST OP THE ORIGINAL AXIS. BUT OTHERWISE PHYSICIAN HAVE NO EXPLANATION FOR THESE PHENOMENA. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT COMPLAINTS ABOUT BLURRED VISION. THE PATIENT'S ISSUES WAS NOT RESOLVED. THE SURGEON PROGNOSIS IS STILL BAD THE PATIENT RECEIVED TOUCH-UP TREATMENT (WITH LASIK).

  Patient problems: Blurred Vision; Dizziness; Headache; Nausea; Visual Disturbances; Visual Impairment

  MAUDE report 16860624 ↗