TECNIS IOL ZLU225 (REF ZLU225U155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474689862), received between Jun 6, 2024 and Jul 28, 2025 — 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 18, 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.

• InjuryJul 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE ZLU225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF DECREASE IN VISION, GLARE, HALOES, LIGHT SENSITIVITY, AND A VISUALLY SIGNIFICANT MECHANICAL COMPLICATION, THE PATIENT CONSENTED FOR AN OPERATIVE PROCEDURE AFTER A DISCUSSION OF RISKS AND BENEFITS OF THE SURGERY. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT300 15.5 IOL. THE LIDS, LASHES, AND CONJUNCTIVA WERE THEN METICULOUSLY PREPARED WITH A 5% BETADINE SOLUTION AND THE EYE WAS THEN IRRIGATED WITH BALANCED SALINE SOLUTION MIXED WITH DILUTE BETADINE. THE PATIENT WAS THEN DRAPED AND A WIRE LID SPECULUM WAS PLACED INTO THE SURGICAL EYE. A TORIC MARKER WAS USED TO MARK 8 DEGREES CLOCKWISE OF THE PRIOR TORIC MARKS, AT APPROXIMATELY 97 DEGREES. A 1.0MM SIDE PORT BLADE WAS USED TO CREATE TWO PARACENTESES. VISCOELASTIC WAS INSTILLED INTO THE ANTERIOR CHAMBER AND BELOW THE LENS AND A 2.5 MM SINGLE BEVEL METAL KERATOME BLADE WAS USED TO MAKE THE INITIAL INCISION. THE INTRAOCULAR LENS WAS DISSECTED FROM THE CAPSULAR BAG USING VISCOELASTIC DEVICE AND DIALED INTO THE ANTERIOR CHAMBER. THE LENS WAS CUT IN THIRDS USING MST MICRO-SCISSORS AND EACH

  Patient problems: Halo; Visual Disturbances; Vitreous Loss

  MAUDE report 22638366 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZLU225 15.5 DIOPTER MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS COMPLAINTS OF BEING UNHAPPY WITH THE VISION QUALITY. IOL EXPLANT PROCEDURE WAS CANCELLED AND WILL BE RESCHEDULED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. 13-MAY-2024: ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF SEVERE HEADACHES, HALOS, ¿UNABLE TO READ ANYTHING,¿ DISSATISFIED WITH VISION, AND DECREASED QUALITY OF LIFE. THE EXPLANTED IOL WAS REPLACED WITH A ZCU225 16.5 DIOPTER IOL. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE IOL EXPLANT DECISION. THERE WAS NO COMPLICATION, INCISION ENLARGEMENT, SERIOUS INJURY, SUTURES, AND NO VITRECTOMY DURING THE EXPLANT PROCEDURE. PATIENT STATUS POST-LENS EXCHANGE WAS REPORTED AS VISUAL ACUITY: 20/25, WILL CONTINUE TO FOLLOW POST-OPERATIVELY. FOLLOW-UP IN 3-MONTHS WITH DILATED EXAM. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort; Halo; Headache; Visual Disturbances

  MAUDE report 19474061 ↗