AcrySof™ IQ Vivity™ DFT015 (REF DFT015.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380652421270), received between Jun 1, 2021 and Dec 1, 2025 — classified as 9 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (9 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Product Quality Problem; Product Quality Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE MATERIAL WAS FOUND TO BE DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 23681410 ↗
• MalfunctionNov 14, 2025Scratched Material; Scratched Material

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER ITS DEPLOYMENT IN THE PATIENT'S ANTERIOR CHAMBER, THE SURGEON NOTICED THAT THE IMPLANT WAS SCRATCHED. THE IOL WAS EXCHANGED FOR UNSPECIFIED COMPANY LENS DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553788 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN WAS REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NO HAPPY WITH HER VISION. THE PATIENT WAS COMPLAINING ABOUT GLARE AND PHOTOPHOBIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 23344508 ↗
• MalfunctionAug 7, 2025Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH WAS DETECTED ON THE HAPTIC OF THE LENS, LENS WAS CUT AND REMOVED FROM THE EYE DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738319 ↗
• MalfunctionMar 14, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED DURING CATARACT AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BEFORE FOLDING, THE LENS WAS VISUALLY INSPECTED WHICH WAS IN FLAWLESS CONDITION AND SUBSEQUENTLY IMPLANTED. AFTER IMPLANTATION, A GROOVE APPEARED ON THE PERIPHERY OF THE LENS WHICH WAS LOCATED OUTSIDE THE OPTICAL PART. AS PER REPORTER, THE MALFUNCTION OCCURRED IN THE PHASE OF LENS IMPLANTATION. THE PATIENT HAS NOT BEEN AFFECTED BY THE MALFUNCTION SO FAR. THE SURGEON DECIDED NOT TO EXPLANT THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21604789 ↗
• MalfunctionJan 9, 2025Failure to Eject; Failure to Eject

  A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING THE LENS IMPLANTATION PHASE. AFTER THE LENS LEFT THE CARTRIDGE, THE PLUNGER BECAME STUCK BETWEEN THE PLUNGER AND THE CARTRIDGE NECK. THE LENS WAS EVENTUALLY IMPLANTED WITHOUT DAMAGE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21110811 ↗
• MalfunctionJan 8, 2025Scratched Material; Scratched Material

  A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE PRE-IMPLANTATION CHECK, THE IOL WAS INTACT AND AFTER IMPLANTATION, THE SURGEON DISCOVERED DAMAGE IN THE FORM OF A SCRATCH ON THE PERIPHERY OF THE LENS. SINCE THE DAMAGE DID NOT EXTEND INTO THE OPTICAL PART, THE SURGEON DECIDED NOT TO EXPLANT THE LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101154 ↗
• MalfunctionApr 10, 2024Defective Component; Failure to Eject; Defective Component; Failure to Eject

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT COME OUT OF THE CARTRIDGE PROPERLY. THE LENS WAS REMOVED AND REPLACED WITH BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT IOL CAME OUT OF THE SHOOTER NOT PROPERLY AND SHOOTER WAS DEFECTIVE. THE LEADING HAPTIC HAD SOME PROBLEM. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078401 ↗
• MalfunctionMar 22, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER OVER RIDE THE LENS AND SCRATCHED THE LENS OPTIC. ADDITIONAL INFORMATION HAS RECEIVED AND REPORTED THAT SURGERY WAS COMPLETED ON THE SAME DAY USING THE LENS OF SAME MODEL.

  Patient problems: Insufficient Information

  MAUDE report 18958042 ↗
• MalfunctionMar 18, 2024Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER IMPLANTING FOUND DAMAGE TO THE OPTICS ON THE EDGE OF THE IOL. AFTER THAT THE IOL WAS EXPLANTED AND NEW UNSPECIFIED LENS WAS IMPLANTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922477 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHE WAS HAVING BLACK CRESCENT IN PERIPHERY (NEGATIVE DYSPHOTOPSIA) AND STREAKS OF LIGHT AROUND ANY LIGHT SOURCE REGARDLESS OF DAY OR NIGHT (POSITIVE DYSPHOTOPSIA)(AT 10 AND 4).THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL ELEVEN MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Visual Disturbances

  MAUDE report 18827887 ↗
• MalfunctionFeb 1, 2024Failure to Eject; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH IOL IMPLANT, THEY NOTICED THAT LENS STUCK IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18621013 ↗
• MalfunctionDec 11, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE . SCRATCH ON LENS NOTICED AFTER LENS HAD BEEN INSERTED. IOL LEFT IN PLACE. ONCE LENS INSERTED INTO THE EYE, THE SURGEON NOTICED A SCRATCH ON THE LENS IN THE IOL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18300809 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 17509198 ↗
• MalfunctionMay 31, 2023Failure to Advance; Failure to Advance

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INSERTION OF THE INTRAOCULAR LENS (IOL) INTO THE ANTERIOR CHAMBER OF THE EYE, THE HAPTIC OF THE IOL BECAME STUCK IN THE CARTRIDGE AND DETACHED. THE SURGERY WAS COMPLETED WITHOUT IMPLANTING THE IOL, AS THERE WAS NO SIMILAR LENS AVAILABLE AT THE CLINIC. THERE WAS NO PATIENT HARM. THE PATIENT CONDITION WAS SATISFACTORY. ADDITIONAL INFORMATION RECEIVED STATED THAT, THE POSTERIOR OPTIC WAS STUCK AND REMAINED IN THE CARTRIDGE. THE REMAINING PART OF THE IOL WAS ALREADY IN THE ANTERIOR CHAMBER OF THE EYE AND HAD TO BE CUT INTO PIECES FOR REMOVAL. THE PATIENT'S CONDITION WAS SATISFACTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029227 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING PATIENT HAS DRY EYES AND WAS NOT COMPLIANT WITH HER DROPS. SURGERY WENT WELL AND INTRAOCULAR LENS (IOL) IN GOOD POSITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Headache

  MAUDE report 17028638 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT CAN SEE OKAY AT A DISTANCE (ALTHOUGH NOT AS WELL AS SOMEONE ELSE WHO GOT MULTIFOCAL LENSES DECADES AGO). NEAR TO MODERATE DISTANCE WAS WORSE THAN PRIOR TO SURGERY. IT'S AFFECTING HER ABILITY TO SEE DURING VIDEOCONFERENCES AT WORK, TRIGGERING MIGRAINES, AND SHE HAD INJURIES FROM DIFFICULTY SEEING WHILE DOING WORK AROUND THE HOUSE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT'S DISTANCE VISON WAS SIGNIFICANTLY BETTER, HER INTERMEDIATE AND NEAR VISION WERE SIGNIFICANTLY WORSE THAN PRIOR TO SURGERY AND THIS WAS NEGATIVELY IMPACTING HER LIFE. SINCE THE SURGERY/LENS IMPLANT, SHE HAS MUCH WORSE VISION AT ARMS LENGTH OR NEARER, FOR EXAMPLE, SEEING AT VIDEO MEETINGS, IDENTIFYING TYPING ERRORS ON THE COMPUTER/CELL PHONE, EXTREME DIFFICULTY READING CELL PHONE, HEADACHES AND MIGRAINES TRIGGERED FROM STRAINING TO SEE AT WORK, MINOR INJURIES AND EXTRA TIME REQUIRED DUE TO DIFFICULTY SEEING WHILE DOING TASKS WITH TOOLS SUCH AS THE ELECTRIC DRILL, BEING ABLE TO SEE THE TIMER ON WATCH AT THE GYM, OPENING THE LOCK ON HER LOCKER AT THE GYM, HAVE TO ASK FRIENDS T

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo; Headache

  MAUDE report 16910293 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED STATING THE PATIENT HAD THIRD OPINION AND WAS TOLD THAT THE PATIENT NEEDED DISTANCE GLASSES. THE PATIENT HAD IMPROVED VISION WHILE WEARING GLASSES AND NOTICES HOW BRIGHT AND COLORFUL EVERYTHING WAS THROUGH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16863079 ↗
• MalfunctionApr 6, 2023Scratched Material; Scratched Material

  A MATERIALS MANAGEMENT REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A NICK IN THE LENS. PATIENT CONTACT WAS OBSERVED. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM REPORTED. PATIENT'S SYMPTOMS WERE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691592 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPRESSED THAT THE LIGHT SPREADING WHEN LOOKING AT THE LIGHT SOURCE WAS RESOLVED HOWEVER COMPLAINED OF BLURRY VISION WHEN SHE SEES A DISTANCE OF MORE THAN 1 METER. THE PATIENT'S VISUAL ACUITY WAS 0.4. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, PREVIOUSLY REPORTED PRODUCT SERIAL NUMBER WAS WRONG AND CORRECT SERIAL NUMBER WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15967388 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD COMPLAINTS OF FLUCTUATING VISUAL ACUITY (VA) PARTICULARLY ON CLOUDY DAYS AND DEFOCUS OF DISTANCE. LASIK ENHANCEMENT WAS UNDERTAKEN. FLUCTUATING VA AND DISTANCE DEFOCUS WERE STILL REMAINED. TIME FOR NEUROADAPTATION PASSED. THE PATIENT HAS REQUESTED EXPLANTATION OF IOL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15631277 ↗
• MalfunctionJul 13, 2022Optical Decentration; Optical Decentration

  AN OTHER HEALTHCARE PROFESSIONAL REPORTED THAT 3-4 WEEKS AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD BILATERAL MYOPIC OUTCOME. THE SURGEON THOUGHT THAT THE IOL MIGHT BE SITTING MORE ANTERIOR THAN EXPECTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 15002549 ↗
• MalfunctionMar 30, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE SURGEON NOTICED 3 SCORE MARKS THROUGH THE CENTER OF THE OPTIC. THE SURGEON EXPLANTED THE LENS WITHOUT ISSUE IN THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13949785 ↗
• MalfunctionMar 22, 2022Scratched Material; Scratched Material

  A PHARMACIST REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE SURGEON NOTICE A SCRATCH IN THE LENS. THE LENS WAS REMOVED FROM THE PATIENT'S EYE AND REPLACED WITH A BACK UP LENS DURING THE INITIAL PROCEDURE. NO CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13853505 ↗
• MalfunctionJan 6, 2022Crack; Scratched Material; Crack; Scratched Material

  A PHYSICIAN REPORTED THAT DURING CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WERE SCRATCHES/CRACKS AT OPTIC EDGE OF THE LENS NOTED. LENS WAS EXCHANGED DURING SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176560 ↗