AcrySof™ IQ Vivity™ DAT015 (REF DAT015.165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652424561), received between May 24, 2021 and Sep 27, 2023 — classified as 8 injuries, 1 malfunction.

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

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

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT HAD ISSUES WITH BLURRY VISION AT ALL DISTANCES, THE INTRAOCULAR PRESSURE HAS INCREASED AND AN ADDITIONAL MEDICATION HAS BEEN PROVIDED TO REDUCE THE INCREASED INTRAOCULAR PRESSURE. POST OPERATIVE 2 WEEKS, THE INTRAOCULAR PRESSURE HAS BEEN NORMALIZED AND THE DRUG HAS BEEN STOPPED. THE PATIENT ALSO FEEL FOREIGN BODY SENSATION ABOVE THE UPPER EYE LID, AND ALSO SEES SHADING SOMETIMES.

  Patient problems: Blurred Vision; Dry Eye(s); Foreign Body Sensation in Eye; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 17823207 ↗
• InjuryJun 12, 2023Adverse 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 EXPERIENCED BLURRED VISION, HALO'S, DRY EYES, TIRED EYES AND JUST CANNOT SEE WELL. THE PATIENT WENT BACK TO THE SURGEON THAT PERFORMED THE YAG (YTTRIUM ALUMINUM GARNET) PROCEDURE WHICH DID NOT HELP AT ALL. THE CONSUMER SAW ANOTHER SURGEON IN THE GROUP THAT SAID EVERYTHING WAS FINE WHICH IT WAS/IS NOT. THE PATIENT ALSO WENT TO ANOTHER PHYSICIAN IN THE GROUP WHO PUT IN PLUGS WHICH DID NOT HELP. THE SURGEON ALSO PRESCRIBED THE LUBRICANT EYE DROPS. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER AND STATED THAT, SHE CANNOT SEE CLOSE UP, CANNOT READ ROAD SIGNS UNTIL SHE WAS PRACTICALLY IN FRONT OF THEM CANNOT SEE CLOSE UP, CANNOT SEE VERY WELL AT NIGHT, SHE USED TO SEE HALO'S AROUND HEADLIGHTS AND STREET SIGNS AND CANNOT READ THE PRINT ON THE TV OR SEE UP CLOSE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Eye Pain; Halo

  MAUDE report 17106231 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS ULTIMATELY UNHAPPY WITH VISION AND UNABLE TO ADAPT TO VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS MENTIONED AS "SUBJECTIVE VISUAL DISTURBANCE". NO ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13367891 ↗
• InjuryDec 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS WAS REMOVED". THE PRODUCT IS NOT AVAILABLE TO RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 13119353 ↗
• InjuryDec 3, 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¿S VISION WAS NOT CLEAR AND HAD HAZY VISION. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL 35 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12927701 ↗
• InjurySep 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A SURGICAL TECHNOLOGIST REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT VISION WAS NOT GOOD, LENS WOULD NOT STAY IN PLACE. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12522871 ↗
• MalfunctionSep 7, 2021Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS NOTICED DEFECTIVE. LENS HAS A SCRATCH ACROSS THE OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432180 ↗
• InjuryAug 10, 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 STARBURSTS AT NIGHT. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL PROCEDURE.

  Patient problems: Visual Disturbances

  MAUDE report 12302414 ↗
• InjuryMay 24, 2021Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED HYPEROPIC OUTCOME WITH A SMALL SCRATCH ON THE LENS WHICH DID NOT AFFECT THE OUTCOME. THE LENS WAS EXCHANGED FROM 16.5 TO 17.5 DIOPTER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 11869291 ↗