AcrySof™ IQ Vivity™ DAT015 (REF DAT015.240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652424714), received between Nov 25, 2021 and Dec 20, 2023 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR DISTANCE VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS FINAL REFRACTIVE ERROR WAS CONSIDERABLY OFF FROM A PLANO TARGET.

  Patient problems: Blurred Vision

  MAUDE report 18363018 ↗
• MalfunctionOct 27, 2023Scratched Material; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED. THE LENS STILL REMAINS IMPLANTED IN PATIENT'S EYE.

  Patient problems: Insufficient Information

  MAUDE report 18019874 ↗
• InjuryJun 27, 2022Malposition of Device; Malposition of Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE BECAUSE OF THE ZONULAR DAMAGE HE COULD NOT CENTER THE LENS AND SAID THE IT WOULD NOT HURT MY VISION BECAUSE PATIENT HAVE SMALL EYES AND THE LENS IS OVER THE PUPIL. PATIENT EXPERIENCED FOG, BLURRED AND CLOUDY VISION, CANNOT SEE GOOD AT ALL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 14826906 ↗
• MalfunctionMay 31, 2022Crack; Crack

  A MATERIALS MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACK IN CENTER OF THE LENS. THE IOL WAS IMMEDIATELY EXPLANTED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT THE CRACK/DEFECTIVE IOL NOTED ONCE EXPRESSED FROM CARTRIDGE. IT CLEARLY WAS NOT A SCRATCH THAT COULD HAVE RESULTED FROM IMPROPER LOADING, IMMEDIATELY PERFORMED IOL EXCHANGE REMOVING DEFECTIVE IOL AND REPLACING IT WITH A NEW LENS. THERE WAS NO PATIENT HARM AND NO HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548277 ↗
• InjuryMay 25, 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, THE PATIENT EXPERIENCED BLURRED VISION, HALOS AND POOR VISION. THE LENS WAS EXCHANGED LATER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE 2 FILES ASSOCIATED WITH THESE EVENTS. THIS IS FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 14495708 ↗
• MalfunctionJan 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, THE PATIENT COULD NOT SEE WELL AT DISTANCE. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS ¿ SUBOPTIMAL REFRACTIVE OUTCOME¿. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13368065 ↗
• InjuryNov 25, 2021Adverse 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, THE PATIENT NOTICED OCCASIONAL "PULSATING" LIKE DARK TO LIGHT ONE WEEK POST OP. SHE STATED DOESN'T NOTICE IT IN DARK ROOM. OCCASIONAL FLOATER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment; Vitreous Floaters

  MAUDE report 12876112 ↗