TECNIS IOL ZCU225 (REF ZCU225U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474659018), received between Feb 18, 2021 and Apr 24, 2025 — 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 18, 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.

• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ZCU225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO COMPLAINTS OF BLURRY VISION AT DISTANCE WITH A CONSTANT HAZE TO EVERYTHING AND WRONG POWER, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A ZCU300 23.0 DIOPTER IOL. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS NO INCISION ENLARGEMENT, SERIOUS PATIENT INJURY, SUTURES, NOR VITRECTOMY. PATIENT PROGNOSIS POST LENS EXCHANGE PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 21905308 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO MYOPIC SURPRISE. IT WAS REMOVED AND REPLACED DURING A SECONDARY SURGICAL PROCEDURE WITH A DCB00 LENS. THERE WAS NO INJURY AND INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 21627594 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SOME VISUAL DISTURBANCES MONTHS OUT WITH THE LENS. THE SYMPTOMS WERE DESCRIBED AS HALOS/GLARES, AND LIGHT SENSITIVITY AT NIGHTTIME. IT WAS CONFIRMED THAT THERE WAS NO LOSS OF 2 OR MORE LINES OF BEST CORRECTED VISUAL ACUITY (BCVA) AFTER IMPLANTATION AND THE PATIENT WAS NOT DEBILITATED, THAT THE PATIENT WAS JUST BOTHERED BY SYMPTOMS. THE DOCTOR INDICATED THAT A YTTRIUM-ALUMINUM GARNET (YAG) PROCEDURE WAS PERFORMED ON (B)(6) 2020 TO TREAT POSTERIOR CAPSULE OPACIFICATION (PCO). REPORTEDLY, THE PATIENT HAS IMPROVED AND NO LONGER IS BOTHERED BY THE SYMPTOMS. THE DOCTOR IS MONITORING THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 11341955 ↗