AcrySof™ IQ Vivity™ DFT315 (REF DFT315.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652421669), received between May 19, 2021 and Nov 21, 2023 — classified as 6 injuries, 3 malfunctions.

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

• InjuryNov 21, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED STATING THAT THE PATIENT HAD NOT RECOVERED. HE WAS BEING FOLLOWED BY A CORNEA SURGEON CONCURRENTLY AND THEY WERE DECIDING IF HE NEED A PARTIAL TRANSPLANT OR NOT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Abrasion; Visual Impairment

  MAUDE report 18184094 ↗
• InjurySep 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS NOT STRONG FOR READING AND EXPERIENCED GLARES. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT SURGEON'S OPINION ON CAUSE OF OUTCOME WAS LENS POSITION TOO POSTERIOR.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17823927 ↗
• MalfunctionJan 4, 2023Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THERE WERE FAULTY LENSES.

  Patient problems: Insufficient Information

  MAUDE report 16093151 ↗
• 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 SAID 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. ADDITIONAL INFORMATION RECEIVED AND STATED THAT AFTER SURGERY PATIENT NEED GLASSES FOR DRIVING AND HAS NIGHT TIME HALOS AND THE OUTCOME WAS MORE MYOPIC THAN PREDICT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 14337454 ↗
• MalfunctionFeb 28, 2022Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS SCRATCHED, BUT NOT SURE IF IT IS A QUALITY ISSUE OR ANY MANIPULATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13620083 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A OPHTHALMIC ASSISTANT REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION WITH UNSATISFACTORY BEST CORRECTED VISUAL ACUITY. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL APPROXIMATELY 1 MONTH FOLLOWING THE INITIAL PROCEDURE. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13251798 ↗
• MalfunctionOct 13, 2021Defective Component; Defective Component

  A FACILITY REPRESENTATIVE HAS REPORTED A FAULTY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624057 ↗
• InjuryMay 27, 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 NEAR VISION NOT GOOD ENOUGH. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR CLINICAL REASON OF DYSPHOTOPSIA WITH DIFFERENT MODEL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 11891986 ↗
• InjuryMay 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND IRREGULAR ASTIGMATISM OF THE LENS. THE IOL EXCHANGED FOR ANOTHER LENS ONE WEEK FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11846568 ↗