AcrySof™ IQ Vivity™ DAT315 (REF DAT315.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652427142), received between Oct 1, 2021 and Oct 19, 2022 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Power Calculation Error” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionOct 19, 2022Crack; Crack

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LINEAR CRACK WAS OBSERVED AFTER THE INSERTION OF IOL WAS IN TO THE PATIENTS EYE. THE SURGEON REMOVED THE IOL A REPLACED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS HAD A CRACK IN IT, NOT EVIDENT UNTIL IMPLANTATION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15631194 ↗
• InjuryFeb 14, 2022Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DUE TO REFRACTIVE MISS OF -3.60D. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13520668 ↗
• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT'S VISION WAS UNACCEPTABLE DUE TO POWER. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13503992 ↗
• InjuryJan 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED A MONTH AFTER IMPLANTATION DUE TO POOR VISION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 13247900 ↗
• InjuryDec 28, 2021Adverse 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 VISION HAZY/ UNCLEAR AND UNDER CORRECTION. THEY HAVE PLANNED TO EXPLANT THE LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT THE LENS WAS EXPLANTED FOR A ANOTHER LENS IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13095221 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE ARE MULTIPLE PATIENTS HAVING MYOPIC OUTCOMES AFTER LENS IMPLANTATION. ADDITIONAL INFORMATION WAS PROVIDED. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO CLINICAL ISSUES IMPACTING PREOPERATIVE MEASUREMENTS AND POSTOPERATIVE VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

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

  MAUDE report 12861075 ↗
• MalfunctionNov 11, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE SURGEON FOUND STANDS OF LINT ON THE POSTERIOR SURFACES OF LENS. THE SURGEON DID IRRIGATION AND ASPIRATION AND TOOK IT OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797123 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED BLURRY VISION, REFRACTION SHOWS RESIDUAL CYLINDRICAL. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE WITHIN 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12715394 ↗
• InjuryOct 1, 2021Optical Decentration; Optical Decentration

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD REDUCTION OF BEST CORRECTED ACUITY AND COMPLAINTS OF DISTORTION. THE PATIENT HAD MILDLY DECENTERED IOL. CAPSULORHEXIS WAS SMALL AND SHOWED EARLY FIBROSIS (1+ PCO) AND A MILDLY ASYMMETRIC PHIMOTIC HEALING PATTERN. ADDITIONAL INFORMATION WAS REQUESTED, RECEIVED AND REPORTED THAT THE PATIENT HAD LENS REPOSITIONING.

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

  MAUDE report 12559177 ↗