AcrySof™ IQ Vivity™ DFT315 (REF DFT315.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652421706), received between Nov 11, 2021 and Apr 8, 2024 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED INTO THE PATIENT'S EYE AND OBSERVED A CRACK ON LENS. THE LENS WAS EXPLANTED AND INSERTED A NEW LENS IN THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059553 ↗
• MalfunctionApr 5, 2024Defective Device; Defective Device

  A PHYSICIAN REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL), PLACEMENT FAILURE. NO INFORMATION AVAILABLE ON THE NATURE OF THE DEFECT OBSERVED, NOR ON ITS POTENTIAL CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19052257 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT A PATIENT WAS NOT COMPLETELY SATISFIED WITH THE VISION; THE VISION WAS NOT AS GOOD AS HOPED. THE PATIENT APPARENTLY ALSO HAD MACULAR EDEMA AFTER THE OPERATION. BUT HE WAS ALSO DISSATISFIED WITH THE COST OF THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PATIENT EXPERIENCED HYPEROPIA AND DID NOT RESPOND IN A GOAL DIRECTED MANNER. HAD BEEN ON DEXA GENTAMICIN EYE DROPS 5X DAILY. SURGERY FOR RIGHT EYE WAS PLANNED FOR 17-MAY. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DIAGNOSIS WAS FOUND TO BE EPITHELIAL EDEMA. PATIENTS SYMPTOMS HAD BEEN RESTORED. EYE DROPS WAS USED AS A MEDICAL INTERVENTION.

  Patient problems: Macular Edema; Visual Impairment

  MAUDE report 18967367 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE PATIENT'S SYMPTOMS DISAPPEARED AFTER EXPLANATION IN SECONDARY PROCEDURE. THE PATIENT HAD A HISTORY OF CATARACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 18875148 ↗
• InjuryAug 22, 2023Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT DURING SURGERY, THEY NOTICED THAT AN INCIDENT OCCURRED WITH THE COMPANY WHEN PICKING UP THE IOL, WHICH WAS USUALLY PICKED UP AT THE JUNCTION OF THE IOL WITH THE IOL LEG, THE LEG REMAINED IN THE MOUNT WHILE THE LENS WAS LIFTED WITH TWEEZERS. IOL WAS NOT IMPLANTED, THE PATIENT WAS LEFT WITHOUT AN IOL (APHAKIA). THE OPHTHALMOLOGIST REQUESTED REPLACEMENT OF THE SUSPECTED IOL AS SOON AS POSSIBLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT OPERATION PERFORMED WITH A REPLACEMENT LENS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595102 ↗
• InjuryJul 24, 2023Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION WHEN THE PATIENT HAD RETURNED BACK TO THE DOCTORS OFFICE, IT WAS CONFIRMED THROUGH SOME TESTS THAT THERE WAS AN ALTERATION ON THE SURFACE OF THE LENS. IT WAS SUGGESTED THAT A REOPERATION HAS TO BE DONE TO CHANGE THE LENS IN THE PATIENTS RIGHT EYE. IT IS STILL UNCLEAR IF THE LENS HAD BEEN CHANGED OR NOT AS A FUTURE DATE ON (B)(6) 2023 WAS GIVEN FOR THE CHANGE OF LENS. ADDITIONAL INFORMATION HAS BEE REQUESTED AND RECEIVED STATING AN APPARENT SCRATCH OR FIBRIN WAS OBSERVED ON THE ANTERIOR SURFACE OF THE IOL THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY COMPLICATIONS. POST SURGERY THE PATIENT HAD COMPLAINED OF BLURRY VISION. ON AN UNSPECIFIED DATE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND WAS REPLACED WITH ANOTHER LENS. THE CONDITION OF THE PATIENT IS IMPROVING.

  Patient problems: Blurred Vision

  MAUDE report 17375895 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS NOT HAPPY WITH THE OVERALL OUTCOME OF THE SURGERY. IMMEDIATELY POST SURGERY THE PATIENT VISION WAS ALRIGHT. AFTER REACHING TO (B)(6) THE PATIENT INITIALLY HAD ISSUES OF A LOT OF GLARE. RECENTLY THE VISION FOR FAR AND NEAR WAS NOT SATISFACTORY AND NEEDED GLASSES ALL THE TIME THOUGH THE COMPLAIN ABOUT GLARE HAD REDUCED. ALSO COMPLAINED OF VISUAL DISTURBANCES AND VISION WAS NOT IN THE OPTIMAL RANGE. A YAG WAS PERFORMED. AN LENS EXCHANGE ALSO HAS BEEN ADVISED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT HAD EXPERIENCED HALOS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.

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

  MAUDE report 16863073 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON FURTHER REVIEW OF THE PREVIOUS INFORMATION, IT WAS IDENTIFIED THAT, THE EVENT OF GRADUAL FALL OF VISION WAS THE PATIENT CURRENT COMPLAINT AT THE TIME OF THE CATARACT SURGERY (PRE-OPERATIVE). THE PATIENT WAS GIVEN LEFT EYE WITH MICRO INCISION CATARACT SURGERY (MICS) WAS ACTUALLY A CATARACT SURGERY PERFORMED FOR LEFT EYE AND IOL 25 MMHG WAS OF BEFORE SURGERY. THE PATIENT WAS TREATED WITH MEDICATION (ANTI-INFLAMMATORY DRUG, ANTIBIOTIC EYE DROP, OPHTHALMIC LUBRICANTS EYE DROP, ARTIFICIAL TEARS GEL ONCE DAILY BEFORE BED, TAB ON-STEROIDAL ANTI-INFLAMMATORY DRUGS TAKE ONLY IN CASE OF PAIN) DURING THE CATARACT SURGERY. HENCE EVENTS CODES HAVE BEEN REMOVED AS IOL WAS NOT THE CONTRIBUTORY CAUSE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment

  MAUDE report 16519407 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE, PATIENT HAD INTRAOCULAR PRESSURE OF 25 MMHG. ON (B)(6) 2023 THE PATIENT WAS ADMITTED AND DISCHARGED ON THE SAME DAY. THE PATIENT WAS COMPLAINTS OF GRADUAL FALL OF VISION AND WAS DIAGNOSED WITH LEFT EYE CATARACT. THE PATIENT WAS GIVEN LEFT EYE WITH MICS (MICRO INCISION CATARACT SURGERY) WITH PC IOL IMPLANTATION (IMPORTED FOLDABLE, EXTEND DEPTH OF FOCUS, TORIC LENS) UNDER LOCAL ANAESTHESIA. ANTI INFLAMMATORY DRUG, ANTIBIOTIC EYE DROP, OPHTHALMIC LUBRICANTS EYE DROP, ARTIFICIAL TEARS GEL ONCE DAILY BEFORE BED, TAB ON-STEROIDAL ANTI-INFLAMMATORY DRUGS TAKE ONLY IN CASE OF PAIN.

  Patient problems: Halo; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment

  MAUDE report 16511746 ↗
• MalfunctionDec 28, 2022Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE DOCTOR IMPLANTED THE LENS IN THE PATIENT'S EYE, IT SEEMED LIKE IT WAS DIFFICULT TO SLIDE THE LENS THROUGH THE CARTRIDGE. THE CARTRIDGE BROKE AT THE TIP AND SCRATCHED THE LENS; THE DOCTOR DIDN'T REALIZE IT UNTIL THE LENS UNFOLDED INSIDE THE EYE AND WAS SEEN TO BE SCRATCHED FROM THE CENTER OF THE LENS. THE DOCTOR DECIDED TO REMOVE THE LENS. SHE BROKE IT WITH TWEEZERS AND REMOVED IT. THE CIRCULATING NURSE PROVIDED THE NEW IOL TO THE DOCTOR SO THAT SHE COULD LOAD IT AGAIN AND IMPLANT IT; THIS LENS WAS ABLE TO BE IMPLANTED CORRECTLY BY THE DOCTOR WITHOUT ANY SETBACKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059282 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE CLINICAL REASON WAS REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 2 MONTHS AFTER INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12796546 ↗