AcrySof™ IQ Vivity™ DAT315 (REF DAT315.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652427128), received between Jun 14, 2021 and Jan 25, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION,THE PATIENT WAS UNHAPPY WITH VISION. AT 1-2 WEEK FOLLOW UP, THE PATIENT HAD POSTERIOR CAPSULE OPACIFICATION (PCO) AND PATIENT WAS ENCOURAGED TO COMPLETE DROP REGIMEN AND EXPECT IMPROVEMENT WITH TIME. AT 3 MONTH APPOINTMENT, IOL STILL LOOKS WELL-POSITIONED WITHIN FEW DEGREES AT MOST OF INTENDED AXIS. PATIENT ASKED TO LUBRICATE AND COME BACK IN A WEEK FOR REPEAT MEASUREMENTS. THE PHYSICIAN REPORTED ABOUT RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 16241031 ↗
• MalfunctionAug 19, 2022Defective Device; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Defective Device; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  A MATERIALS MANAGEMENT REPORTED THAT APPROXIMATELY AFTER 4 MONTHS OF IMPLANTATION OF AN INTRAOCULAR LENS (IOL), EXPLANTED INTRAOCULAR LENS DUE TO BLURRY VISION AND REFRACTIVE SURPRISE. THE LENS WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT LENS WAS REPLACED WITH DIFFERENT MODEL WITH SAME DIOPTER. HENCE THE FILE WAS CONSIDERED AS NON-REPORTABLE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT, IN THE SURGEON'S OPINION THE LENS HAS THE ISSUE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15257163 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO READ AND DO COMPUTER WORK. HER DISTANCE VISION WAS 20/20. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 13110573 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SHADOWS AROUND VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL THREE MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. SURGEONS OPINION LENS EXPLANTED DUE TO COMPANY IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12376583 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED COLORS WERE NOT WHAT THEY SHOULD BE, COLOR WERE OFF SINCE SURGERY, FOR INSTANCE FLUORESCENT LIGHTS APPEAR GREEN OR PURPLE, WORSE AT CERTAIN TIMES OF THE DAY AND WORSE IN ARTIFICIAL LIGHT THEN SUNLIGHT. THE SYMPTOMS WERE ONGOING. THE IOL WAS EXPLANTED AND EXCHANGED 42 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12154416 ↗
• MalfunctionJun 14, 2021Scratched Material; Scratched Material

  A PURCHASING AGENT REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS SCRATCHED NOTICED. THE IOL WAS EXCHANGED WITH BACKUP LENS DURING INITIAL PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995611 ↗