AcrySof™ IQ Vivity™ DFT315 (REF DFT315.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652421676), received between May 4, 2021 and Aug 7, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTHCARE PROFESSIONAL REPORTED THAT, THE SURGEON HAD DOUBTS ABOUT THE INTEGRITY OF THE TRAILING HAPTIC WHEN HANDLING THE IMPLANT, CHOSE NOT TO IMPLANT IT. THEY USED THE BACKUP IMPLANT INSTEAD, AND EVERYTHING WENT WELL. NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745574 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT DID NOT MEET VISION SATISFACTION OUTCOME. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DESIRED POSTOPERATIVE REFRACTION NOT MET. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19919379 ↗
• MalfunctionJun 6, 2024Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING SURGERY, THEY NOTICED THAT A SCRATCH ON THE LENS. SURGEON IMPLANTED IT, WHILE FIXING/REPOSITIONING LENS AS PER RECOMMENDED AXIS. NOTICED THAT THERE¿S A SCRATCH ON THE LENS. LENS WAS TORN APART AS SURGEON HAD TO CUT IT A FEW TIMES TO TAKE IT OUT OF THE EYE. THERE WAS NO POST OP COMPLICATION. EVERYTHING WENT WELL PROCEDURE WISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475053 ↗
• InjuryJul 4, 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 BURRED DISTANCE AND NEAR VISION. HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 14908110 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BAD GLARE AT NIGHT, ALSO HAVE HALOS SURROUND ANY LIGHT AT NIGHT WHICH MAKES DRIVING VERY DIFFICULT AND HAVE A HARD TIME FOCUSING ON CLOSE OBJECTS AND READING SMALLER PRINT. PATIENT CAN SEE THE EDGES OF THE LENSES AT ALL TIMES, AND THEY SEEM TO FLASH AND AS PER SURGEON IT WAS PERIPHERAL VISION STRETCHING, HOWEVER NOTHING HAS IMPROVED. THE SURGEON TOLD THAT EYES WOULD NEED TIME TO ADJUST SINCE PATIENT HAVE VERY BLURRY VISION AFTER 4 FEET. ADDITIONAL INFORMATION WAS PROVIDED STATED THAT PATIENT HAD A BAD GLARE ALL THE TIME AND WAS VERY COMPARABLE TO WEARING AN EXTREMELY DIRTY PAIR OF GLASSES THAT ARE COVERED IN FINGER PRINTS. PATIENT SEE THE SIDES OF THE LENSES ALL THE TIME AND THEY SEEM TO PULSATE WHEN PATIENT TRY TO LOOK AT AN OBJECT. ON (B)(6) 2022, CONSUMER HAD THE YAG LASER TREATMENT AND EYES DIDN¿T IMPROVE. CONSUMER NOT ABLE TO READ THE SPEEDOMETER OR PRINT. NO FURTHER INFORMATION AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 14333920 ↗
• MalfunctionMay 4, 2021Scratched Material; Scratched Material

  A SURGICAL TECHNOLOGIST REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THAT THE IOL WAS SCRATCHED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE SCRATCH WAS NOTED WHEN THE LENS WAS IMPLANTED. FURTHER INFORMATION WAS PROVIDED THAT THE IOL WAS REMOVED DURING THE INITIAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769664 ↗