TECNIS IOL ZCU225 (REF ZCU225U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474658950), received between Feb 25, 2021 and Jul 11, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (1 report).

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.

• InjuryJul 11, 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 PATIENT PREFERENCE TO CHANGE FROM A TORIC TO A MULTI-FOCAL LENS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRT225 19.0 IOL. THERE WAS NO MEDICAL INTERVENTION, NO PATIENT INJURY, AND NO SURGICAL INTERVENTION DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST LENS EXCHANGE PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22487654 ↗
• MalfunctionFeb 25, 2021Unstable; Unstable

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A STUDY SUBJECT AND THE OPERATIVE IOL AXIS ESTIMATE RIGHT EYE (OD) WAS 114 DEGREES. BUT AT 3-MONTH STUDY POSTOPERATIVE IOL AXIS ESTIMATE OD: 102 DEGREES. UNCORRECTED VISUAL ACUITY OD AT THE 3-MONTH POSTOPERATIVE VISIT: 20/12.5. MANIFEST REFRACTION: PLANO. BEST-CORRECTED DISTANCE VISUAL ACUITY: 20/12.5. SUBJECT REPORTED NO VISUAL SYMPTOMS AT THIS VISIT. NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME. THE COMPLAINT WAS BASED UPON A SUBJECTIVE ESTIMATE MADE BY THE INVESTIGATOR FROM A SLIT-LAMP MEASUREMENT. FOR THIS STUDY, WE HAVE ALSO BEEN DOING INDEPENDENT ANALYSIS OF THE IOL PHOTOS TAKEN AT EACH VISIT. THESE ARE OBJECTIVE MEASUREMENTS OF THE ACTUAL IOL AXIS. BASED ON THIS OBJECTIVE MEASUREMENT, THE ACTUAL AMOUNT OF IOL ROTATION FOR THE SUBJECT BELOW IS LESS THAN 01 DEGREE. THERE IS STILL NO SURGICAL INTERVENTION PLANNED. THE SUBJECT HAS COMPLETED THE STUDY. SUBJECT: (B)(6). VISIT SCHEDULE: PO 3 MONTH. PAGE: ANALYST 1 REVIEW. STUDY EYE: OD. DELTA ANGLE FROM BASE: 0.075. SUBJECT: (B)(6). VISIT SCHEDULE: PO 3 MONTH. PAGE: ANALYST 2 REVIEW. STUDY EYE: OD. DELTA ANGLE FROM BASE: 0.659.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376938 ↗