AcrySof™ IQ Vivity™ DAT015 (REF DAT015.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652424660), received between Mar 15, 2021 and Nov 3, 2023 — classified as 17 injuries, 4 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

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

  A FACILITY REPRESENTATIVE REPORTED AN THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED LOSS OF BEST VISION WITH HEADACHES. CLINICAL REASON FOR EXPLANT WAS INTOLERABLE DYSPHOTOPSIA AND LOSS OF BEST CORRECTED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL ONE YEAR EIGHT MONTHS TWENTY DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Headache; Visual Disturbances

  MAUDE report 18064039 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POSSIBLY COMBINATION OF HOAS (HIGHER ORDER ABERRATIONS) AND NEUROADAPTATION ISSUES. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Visual Impairment

  MAUDE report 16910296 ↗
• MalfunctionMay 8, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS SCRATCHED AFTER IMPLANTING. ADDITIONAL INFORMATION WAS REPORTED AS THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16888703 ↗
• InjuryApr 10, 2023Adverse 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 EXPERIENCED BLURRY VISUAL ACUITY. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS 20/40 BCVA, UNRETRACTABLE PART 20/40, 20/20 E MONOFOCAL. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Blurred Vision

  MAUDE report 16707326 ↗
• MalfunctionMar 16, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS PROVIDED AS THE 21.5D LENS WAS EXCHANGED FOR A 21.5D COMPANY LENS.

  Patient problems: Blurred Vision

  MAUDE report 16552529 ↗
• MalfunctionDec 27, 2022Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FOUND TO BE DEFECTIVE. SURGERY WAS SUCCESSFULLY COMPLETED USING BACKUP LENS. THERE WERE NO POST OPERATION COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16049666 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION, BEST CORRECTED VISUAL ACUITY (BCVA) 20/30. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES THERE WAS NO PATIENT HARM. IT IS UNKNOWN IF THE PATIENT¿S ISSUES HAVE BEEN RESOLVED. THE DOCTOR¿S STILL WAITING TO SEE THE PATIENT FOR POST-OPERATIVE APPOINTMENT.

  Patient problems: Blurred Vision

  MAUDE report 15266701 ↗
• InjuryJul 4, 2022Adverse 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 UNHAPPY WITH RANGE OF VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 4 MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS EXTENDED DEPTH OF FOCUS (EDOF) LENS DID NOT PROVIDE SUFFICIENT NEAR VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14907414 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED CLOUDY VISION. THE PATIENT WAS PRESCRIBED WITH GLASSES, BUT UNABLE TO READ WITHOUT THEM, BUT THINGS ARE STILL CLOUDY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 14852800 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT WAS NOT HAPPY WITH VISION AND EXPERIENCED BLURRINESS. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14285354 ↗
• InjuryApr 19, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MYOPIC OUTCOME DUE TO WRONG POWER. THE IOL WAS REMOVED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 14140717 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRY DISTURBED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PATIENT UNHAPPY WITH BLURRED VISION DESPITE REFRACTIVE CORRECTION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 14111372 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADMINISTRATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED DUE TO UNSPECIFIED REASONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367363 ↗
• InjuryJan 5, 2022Adverse 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 HAD VISUAL DISTURBANCES. THE PATIENT CONTINUED BLURRED/FLUCTUATING VISION AND DIFFICULTY WITH GLARE AT NIGHT. THE PATIENT COULD NOT ADAPT TO THE LENS. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL APPROXIMATELY 6 MONTHS FOLLOWING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13170048 ↗
• InjuryDec 29, 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 IOL WAS EXCHANGED IN A SECONDARY PROCEDURE TWO MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MYOPIC SURPRISE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13112945 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED, FROM THE INITIAL REPORTER. AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL, BUT ONE DIOPTER LESS POWER, INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision

  MAUDE report 12591859 ↗
• MalfunctionSep 24, 2021Crack; Crack

  AN ACCOUNT MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS CRACKED OBSERVED IN THE EYE. THE LENS WAS STILL IN THE PATIENT'S EYE BUT THEY SCHEDULED FOR A LENS EXPLANT. ADDITIONAL INFORMATION WAS RECEIVED FROM PHYSICIAN, WHO REPORTED THAT THE PATIENT HAD A DENSE CATARACT WHICH REQUIRED INCREASED PHACO ENERGY WHICH MADE THE CORNEA HAZY. IT WAS DIFFICULT TO TELL FOR CERTAIN IF THERE WAS A CRACK SO WAITING FOR THE CORNEA TO CLEAR POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12529842 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED EXPLANTED INTRAOCULAR LENS, SHADOW WHEN SEEING LIGHTS OR LOOKING AT A COMPUTER, INTOLERANCE OF IOL WITH DOUBLE VISION & POOR QUALITY VISION. POST IMPLANTATION AFTER 12 DAYS THE LENS WAS REPLACED WITH OTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 12048517 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, MYOPIC REFRACTIVE SURPRISE NOT CORRECTABLE OR BETTER WITH REFRACTION. THE IOL EXCHANGED FOR ANOTHER LENS IN 6TH WEEK FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11960141 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT WAS NOT HAPPY WITH THE VISUAL OUTCOME. THE IOL WAS EXCHANGED 3 WEEKS AFTER THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 11913858 ↗
• InjuryMar 15, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS TWISTED UPON ITSELF AND AFTER THE IOL WAS INJECTED INTO THE CAPSULAR BAG, THE LEADING HAPTIC REMAINED TWISTED BUT TO RELEASE WITHOUT MANIPULATION. AS THE IOL WAS CENTERED INTO THE BAG WITH A GENTLE NUDGE OF THE SINKSY HOOK, IT WAS NOTED THAT THE ENTIRE LEADING HAPTIC WAS AMPUTATED AT ITS BASE. FORCEPS WERE USED TO REMOVE THE HAPTIC. THE IOL WAS SLIGHTLY DECENTERED DUE TO THE MISSING HAPTIC SO THE HAPTIC AND IOL WERE REMOVED THROUGH AN ENLARGED INCISION USING SCISSORS AND COPIOUS VISCOELASTIC. A BACKUP IOL WAS INJECTED INTO THE CAPSULAR BAG AND AN INTERRUPTED NYLON SUTURE WAS USED TO SECURE THE MAIN TEMPORAL INCISION. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11485002 ↗