AcrySof™ IQ Vivity™ DAT015 (REF DAT015.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652424653), received between May 4, 2021 and Nov 14, 2023 — classified as 15 injuries, 3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DISSATISFIED WITH QUALITY OF VISION AND CONTRAST SENSITIVITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS EXCHANGE WENT WELL, BUT DUE TO CONCERN THAT POSTERIOR CAPSULE WAS NOT INTACT, THE PHYSICIAN ENDED UP PLACING ANOTHER COMPANY LENS IN THE SULCUS.

  Patient problems: Visual Disturbances

  MAUDE report 18131546 ↗
• InjuryJun 9, 2023Adverse 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 VISION BLURRY ALL DISTANCE AND PATIENT WAS UNABLE TO ADAPT TO MULTIFOCAL LENS . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 14 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS MYOPIC SURPRISE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17097405 ↗
• InjuryApr 11, 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 BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16712422 ↗
• MalfunctionMar 16, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS PROVIDED, AS THE 21.0D LENS WAS EXCHANGED, FOR A 21.0D COMPANY LENS.

  Patient problems: Blurred Vision

  MAUDE report 16552527 ↗
• InjurySep 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED MYOPIC REFRACTIVE SURPRISE/SHIFT AND LENS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15443046 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPHTHALMIC TECHNICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH RESULTS, UNABLE TO SEE INTERMEDIATE OR NEAR VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15321349 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PRACTICE ADMINISTRATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TEMPORAL ARC, POOR VISION, AND VISUAL DISCOMFORT. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 6 MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASONS FOR THE EXPLANT WERE DYSPHOTOPSIA, INTOLERABLE TO OPTICS AND INABILITY TO ADAPT. THE PATIENT RECEIVED A REPLACEMENT MONOFOCAL LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING, IN THE SURGEON'S OPINION, A QUALITY ISSUE WITH THE IOL DID CAUSE OR CONTRIBUTE TO THE EVENT INDICATING PATIENT COULD NOT SEE WELL, WAXY VISION, QUALITY ISSUE. IT WAS ALSO INDICATED THAT EXTENDED DEPTH OF FOCUS (EDOF) LENS WAS NOT COMPATIBLE FOR PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Discomfort; Visual Disturbances

  MAUDE report 15294967 ↗
• MalfunctionMay 27, 2022Break; Break

  A PHYSICIAN REPORTED THAT AFTER IMPLANTING INTRAOCULAR LENS (IOL), THE SURGEON NOTICED CRACK ON IOL. THE SURGEON CUT THE LENS OUT AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14522214 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ACCOUNT MANAGER REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING BLURRY VISION AND COULD ONLY BE REFRACTED TO 20/30 - 20/40 RANGE. PATIENT IS AMBLYOPIC. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 14461113 ↗
• InjuryMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE ERROR AND DOCTOR SUGGESTED TO CHANGE LENS POWER. THE LENS WAS LATER EXCHANGED TO THE DESIRED POWER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14404919 ↗
• InjuryFeb 7, 2022Defective Device; Device Dislodged or Dislocated; Defective Device; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED THAT, LENSES ARE DEFECTIVE.

  Patient problems: Blurred Vision

  MAUDE report 13472390 ↗
• MalfunctionNov 12, 2021Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INSERTION OF THE INTRAOCULAR LENS (IOL), NOTICED THAT THERE WAS A SCRATCH ON THE LENS. THE LENS WAS REPLACED AND THE PROCEDURE WAS COMPLETED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805228 ↗
• InjuryNov 12, 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 UVEITIS-GLAUCOMA-HYPHEMA (UGH) SYNDROME AND PERSISTENT IRITIS. THE IOL WAS EXPLANTED DUE TO UGH 44 DAYS AFTER IMPLANTATION AND REPLACED WITH ANOTHER LENS MODEL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Iritis; UGH (Uveitis Glaucoma Hyphema) Syndrome

  MAUDE report 12802644 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING IMPLANTATION OF LENS, THE PATIENT CANNOT SEE AT NEAR WELL, AND DISTANCE IS COMPLETELY BLURRY. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS EXPLANTED WITH ANOTHER LENS IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12743567 ↗
• InjuryOct 28, 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 LENS WAS NOT GIVING HER CORRECT VISION. ADDITIONAL INFORMATION WAS PROVIDED THAT THE IOL WAS REMOVED IN A SECONDARY PROCEDURE DUE TO POOR CONTRAST.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12712350 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED EXPLANTATION OF AN INTRAOCULAR LENS (IOL) WITH A CLINICAL REASON OF ¿PATIENT ONLY HAD NEAR VISION¿ AND A PATIENT REASON OF ¿NO BENEFIT FROM THE LENS¿. THE IOL WAS EXCHANGED WITH AN ALTERNATE LENS APPROXIMATELY 3 WEEKS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 12439300 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY, AND POST OPERATION PATIENT HAD A PHOTOREFRACTIVE KERATECTOMY (PRK) TOUCH UP, AND VISION WAS NOT CLEAR. PATIENT WAS AMBLYOPIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 12274229 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED IMBALANCED VISION AND ANISOMETROPIA. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 11770410 ↗