AcrySof™ IQ Vivity™ DAT015 (REF DAT015.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652424639), received between May 26, 2021 and Oct 27, 2023 — classified as 18 injuries, 2 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THE IOL EXCHANGE WAS DONE WITH A NON-COMPANY LENS. THE PATIENT EXPERIENCED GLARE AND WAS UNHAPPY WITH VISION. THE CLINICAL REASON FOR EXPLANT WAS NEGATIVE DYSPHOTOPSIA.

  Patient problems: Visual Disturbances

  MAUDE report 18020577 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT AFTER SURGERY, PATIENT WAS UNHAPPY WITH THE INTERMEDIATE VISION WITH THESE LENSES, CANNOT READ PHONE. SHE HAD SURGERY ABOUT A YEAR AGO AND HAD NOT IMPROVED. SHE FELT LIKE SHE WAS MISLED BY THE MARKETING THAT SHE WOULD BE ABLE TO SEE ALL DISTANCES WITHOUT GLASSES. SHE HAS HAD A YAG LASER OS (B)(6) 2023. SHE WILL HAVE THE FELLOW EYE YAG LASER NEXT WEEK. SHE WAS TOLD MAYBE LASIK WOULD IMPROVE HER VISION. SHE DID NOT WANT ANY FURTHER SURGERY. HER DISTANCE VISION WAS VERY GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT VISION NOT IMPROVED SINCE YAG LASER. THE SURGEON WHO DID HER LASER WAS NOT THE SURGEON WHO DID HER CATARACT SURGERY. HE NO LONGER WORKS THERE. SHE WAS NOT GOING TO HAVE AN EXPLANT. SHE WILL CALL BACK IN 90 DAYS TO GET THE FINAL RESULT OF INVESTIGATION. ALSO STATED THAT THIS LENS DOES NOT PROVIDE ADEQUATE NEAR VISION. PATIENT DID NOT UNDERSTAND THIS AND LENS DID NOT MEET EXPECTATIONS OF PATIENT.

  Patient problems: Blurred Vision

  MAUDE report 17823531 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAD DOUBLE VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH MONOFOCAL LENS. THE CLINICAL REASON FOR EXPLANT WAS, DIPLOPIA DUE TO SMALL AMOUNT OF RESIDUAL ASTIGMATISM. THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 16571689 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT AND WAS NOT HOSPITALIZED.

  Patient problems: Visual Disturbances

  MAUDE report 16325160 ↗
• InjuryJan 30, 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 MYOPIC RESULT AND BLURRY DISTANCE VISUAL ACUITY STATUS POST LASIK. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MYOPIA. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16264253 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT LENS WAS IMPLANTED, THEN REMOVED AT A LATER DATE. PATIENT REQUIRED VITRECTOMY AND IN THE SULCUS LENS UNEXPECTEDLY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15930886 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED BLURRED VISION AND REFRACTIVE ERROR. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER MODEL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15713217 ↗
• InjuryOct 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THERE WAS AN ISSUE WITH THE DISTANCE VISION, HENCE THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15660913 ↗
• InjuryAug 23, 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 LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15273720 ↗
• InjuryJun 9, 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 EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE ONE MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED

  Patient problems: Blurred Vision

  MAUDE report 14647104 ↗
• MalfunctionApr 26, 2022Break; Failure to Advance; Break; Failure to Advance

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL GOT STUCK INTO THE INJECTOR AND THE HAPTIC BROKE, THE LENS WAS REMOVED AND THE NEW IOL WAS PLACED WITHOUT COMPLICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14208614 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD UNSATISFACTORY VISUAL OUTCOME. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION.

  Patient problems: Blurred Vision

  MAUDE report 13996185 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS EXTREMELY NEARSIGHTED. SHE ALSO HAD DEVELOPED INFLAMMATION AND SWELLING IN THE EYE AND MACULAR DEGENERATION. ADDITIONAL INFORMATION WAS RECEIVED THAT, HER MILD MACULAR DEGENERATION GOT WORSE. SHE HAD GOTTEN YAG (NEODYMIUM-DOPED YTTRIUM ALUMINUM GARNET) PROCEDURE DONE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR RIGHT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Inflammation; Swelling/ Edema

  MAUDE report 13977962 ↗
• InjuryMar 7, 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 WAS UNABLE TO SEE DISTANCE AND HAVING GLARE AT NIGHT, CLINICAL REASON FOR EXPLANT IS MYOPIC SURPRISE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 13684848 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLUR, GHOSTING AND HALO. THE IOL WAS EXCHANGED FOR ANOTHER LENS AFTER A MONTH OF THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 13521248 ↗
• InjuryFeb 10, 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 INADEQUATE VISUAL FUNCTION NEAR/FAR. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL FOLLOWING THE INITIAL PROCEDURE. POOR NEW FUNCTION IN THE IOL WAS THE CLINICAL REASON MENTIONED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13507111 ↗
• InjuryFeb 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRY VISION, RESIDUAL CYLINDER. THE LENS WAS EXPLANTED IN A SECONDARY SURGERY AND WAS REPLACED WITH A DIFFERENT LENS.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13421391 ↗
• MalfunctionJan 13, 2022Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) FOUND DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13248240 ↗
• InjuryNov 9, 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 DECREASED VISION, CAUSING TROUBLE WITH DAILY ACTIVITIES. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND STATED THAT THERE WAS NO PATIENT HARM AND THE PATIENT WAS NOT HOSPITALIZED.

  Patient problems: Blurred Vision

  MAUDE report 12780938 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRED VISION AFFECTING QUALITY OF LIFE. THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11889986 ↗