enVista® IOL MX60E (REF MXUE1850)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10757770531254), received between Apr 23, 2024 and May 22, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS INTO THE LEFT EYE, THE PATIENT BEGAN TO EXPERIENCE VISUAL DISTURBANCES IN THE FORM OF BLURRY VISION AND NEGATIVE DYSPHOTOPSIA. APPROXIMATELY 3 MONTHS POST-OP, THE LENS WAS EXCHANGED WITH A DIFFERENT MODEL IOL. REPORTEDLY, THE IRIS TORE AND PROLAPSED DURING REMOVAL OF THE IOL AND WORSENED AFTER THE INSERTION OF THE NEW IOL. IN THE SURGEON¿S OPINION, THE LIKELY CAUSE OF THE EVENT WAS "SUBJECTIVE VISUAL DISTURBANCE/TEMPORAL NEGATIVE DYSPHOTOPSIA".

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

  MAUDE report 19372840 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS INTO THE LEFT EYE, THE PATIENT STATED THEIR DISTANCE AND NEAR VISION WASN''T CLEAR. ROUGHLY EIGHTEEN MONTHS POST-IMPLANTATION, THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL IOL. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS DYSPHOTOPSIA. PATIENT OUTCOME IS GOOD. THIS REPORT IS FOR THE PATIENT''S LEFT EYE. RIGHT EYE REFERENCE: 0001313525-2024-00091.

  Patient problems: Visual Impairment

  MAUDE report 19162635 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER THE IMPLANTATION OF AN INTRAOCULAR LENS INTO THE RIGHT EYE, THE PATIENT STATED THEIR DISTANCE AND NEAR VISION WASN''T CLEAR. ROUGHLY EIGHTEEN MONTHS POST-IMPLANTATION, THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL IOL. IN THE SURGEON¿S OPINION, THE MOST LIKELY CAUSE OF THE EVENT IS DYSPHOTOPSIA. PATIENT OUTCOME IS GOOD. THIS REPORT IS FOR THE PATIENT''S RIGHT EYE. LEFT EYE REFERENCE: 0001313525-2024-00090.

  Patient problems: Visual Impairment

  MAUDE report 19162617 ↗