AcrySof™ IQ Vivity™ DAT015 (REF DAT015.150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652424530), received between Jun 9, 2021 and Oct 31, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE SIGHT WAS NOT IMPROVED, THE PATIENT HAD CLOUDY, BLURRY VISION. THE VISION WAS 20/20. THE SURGEON SAID IT WAS SCAR TISSUE AND TO WAIT ABOUT 90 DAYS AND THEY WOULD DO A LASER TO CLEAN OFF THE SCAR TISSUE. IT SEEMED AS IF LOOKING THROUGH A HAZE AT NIGHT. ALSO SEES A SPINNING PINWHEEL IN A LOW LIGHT ROOM. SHE DOES NOT NOTICE IT WHILE DRIVING OR IN BRIGHT LIGHTS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS FURTHER CLARIFIED THAT THE PATIENT CANNOT READ SIGNS IN THE GROCERIES STORE AND THE HAZE AROUND THE LIGHTS AT NIGHT CONTINUED. HAD LASER TO CLEAN OFF LENS SCAR TISSUE AND VISION MAY HAVE BEEN BETTER FOR A DAY OR TWO. NOW VISION IS NOT GOOD AGAIN FOR DISTANCE OR INTERMEDIATE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE PATIENT HAD EXPERIENCED GOOPY MORNING DISCHARGE THAT CAUSES BLURRY VISION IN BOTH EYES. THERE WAS A CREASE IN THE LEFT RETINA.

  Patient problems: Blurred Vision; Corneal Clouding/Hazing; Excessive Tear Production; Retinal Tear; Scar Tissue; Visual Impairment

  MAUDE report 15697864 ↗
• InjuryJun 9, 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) IMPLANTATION PROCEDURE, A PATIENT WAS 20/100 NEAR, UCVA 20/60 INTERMEDIATE WITH A 1 MONTH POST OP MANIFEST REFRACTION (REFRACTION BY SURGEON) OF -0.75 +0.50 OD". ALSO REPORTED THAT THE "PATIENT COMPLAINS CANNOT SEE ANYTHING AT INTERMEDIATE AND NEAR AND WEARS READERS 100% OF THE TIME; 2ND EYE CANCELLED; PATIENT TO FOLLOW UP IN SEVERAL WEEKS". ADDITIONAL INFORMATION WAS PROVIDED INDICATING THE PATIENT DEVELOPED TRACE POSTERIOR CAPSULE OPACIFICATION APPROXIMATELY SEVEN WEEKS FOLLOWING THE INITIAL IMPLANTATION. THEN TWO WEEKS LATER A LIMBAL RELAXING INCISION (LRI) PROCEDURE WAS PERFORMED.

  Patient problems: Blurred Vision

  MAUDE report 11970236 ↗