TECNIS IOL ZCU225 (REF ZCU225U240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474659056), received between Feb 25, 2021 and Jul 9, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN EXPLANT OCCURRED DUE TO A REFRACTIVE SURPRISE. THERE WAS NO PATIENT INJURY REPORTED. THE LENS WAS REMOVED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH THE SAME MODEL BUT A HIGHER DIOPTER INTRAOCULAR LENS. ADDITIONAL INFORMATION REVEALED THAT THERE WAS A CALCULATION ISSUE, AS BOTH THE PENTACAM AND ORA SUGGESTED THE USE OF THIS LENS, BUT THE PATIENT ENDED UP WITH A SIGNIFICANT REFRACTIVE ERROR AFTERWARD. ON (B)(6) 2025, IT WAS NOTED THAT THE PATIENT¿S VISION WAS NOT GOOD. HOWEVER, A ONE-WEEK REFRACTION CHECK REVEALED THAT THE PATIENT STILL HAD A CONSIDERABLE AMOUNT OF ASTIGMATISM THAT NEEDED CORRECTION. THE PATIENT IS DOING BETTER NOW. THERE WAS SOME CORNEAL EDEMA FROM THE SECOND PROCEDURE, BUT IT IS CLEARING UP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 22457938 ↗
• InjuryMay 25, 2021Application Program Problem: Dose Calculation Error; Labelling, Instructions for Use or Training Problem; Application Program Problem: Dose Calculation Error; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) IMPLANTED INTO THE PATIENT'S RIGHT (OD) EYE. THE LENS WAS ORIENTED AT 110°. THE PREDICTED REFRACTION WAS A -.50+ .07 AT 21°. THE SURGEON RAN THE CALCULATION TWICE. HER REFRACTION TODAY IS +1.00+2.00X 010. THE SURGEON REPEATED HER IOL MASTER AND TOPOGRAPHY TODAY AND ONCE AGAIN SHE IS SHOWING 1.95D CYLINDER @100 (HER PREV IOLM SHOWED 1.84D@106). HER CORNEAL TOPOGRAPHY IS CONSISTENT WITH THE READINGS THAT ARE GETTING ON HER IOL MASTER. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE LENS HAS EXPLANTED FROM THE PATIENT'S EYE. THE SURGEON WOULD LIKE TO KNOW IF IOL WAS MISLABELED OR IF IT WAS A MISTAKE ON THEIR END. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 11879384 ↗
• InjuryFeb 25, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  THE CUSTOMER REPORTED THAT A PATIENT COMPLAINED OF GLARE SYMPTOMS AT HIS ONE-MONTH POST-OPERATIVE VISIT AFTER THE IMPLANTATION OF A TORIC INTRAOCULAR LENS (IOL). THE SURGEON DILATED THE PATIENT'S EYE AND SAW A RECTANGULAR FOREIGN BODY BETWEEN THE IOL AND POSTERIOR CAPSULE. THE SURGEON HAS SEEN SMALL CORTICAL/CAPSULAR FRAGMENTS TRAPPED IN THE CAPSULE POST-OPERATIVELY WHICH DISAPPEARED WITH YAG CAPSULOTOMY, SO HE PROCEEDED WITH THE LASER, BUT THE FOREIGN BODY IS EXTREMELY FIRMLY ADHERENT, AND DOESN'T MOVE AT ALL WITH THE LASER. IT ALMOST LOOKS LIKE A PIECE OF PLASTIC OR CELLOPHANE STUCK ONTO THE POSTERIOR SURFACE OF THE IOL. THE LENS REMAINS IMPLANTED AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 11383196 ↗