AcrySof™ IQ Vivity™ DAT015 (REF DAT015.160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652424554), received between Apr 16, 2021 and Jun 12, 2023 — classified as 7 injuries.

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

• 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. THE CONSUMER ALSO 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. THE EYE ALWAYS FEEL DRY AND THE PARTICULAR FEELS DROOPY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Eye Pain; Halo

  MAUDE report 17106230 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED OF POOR DISTANCE VISION AND DOUBLE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. IOL EXCHANGE WAS PERFORMED WITH LRI (LIMBAL RELAXING INCISIONS). AS PER DOCTOR EXPLANT WAS DUE TO VIVITY LENS AND VITREOUS OPACITIES. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

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

  MAUDE report 16476269 ↗
• InjuryNov 29, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 6 WEEK OF INITIAL IMPLANTATION. THE LENS WAS REPLACED WITH NON COMPANY SUBLUXED LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM DURING THE SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15876677 ↗
• InjuryDec 29, 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 VISION WAS EXTREMELY BLURRY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE THREE WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS "SUBJECTIVE VISUAL DISTURBANCE." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13112967 ↗
• InjuryOct 6, 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 EXPERIENCED UNCLEAR DISTANCE VISION, BETTER THAN BEFORE THE SURGERY BUT NOT GOOD ENOUGH TO GO WITHOUT GLASSES. THE PATIENT RECEIVED COLD LASER TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 12583479 ↗
• InjuryOct 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND MYOPIA. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED PRIOR TO THE IOL EXCHANGE, A PROCEDURE WAS PERFORMED TO REPOSITION THE IOL WITH A SUTURE. THE SURGEON STATED THE OPTICS OF THE COMPANY (IMPLANTED) LENS MAY NOT WORK WITH THE PATIENT'S EYE, THEREFORE THE IOL WAS EXCHANGED 29 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 12582428 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED 1 MONTH AFTER IMPLANTATION DUE TO POOR INTERMEDIATE VISION AND POOR DISTANCE VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11679690 ↗