TECNIS IOL ZCU225 (REF ZCU225U060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474658691), received between Jun 30, 2023 and Aug 20, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 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.

• MalfunctionAug 20, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT¿S EYE. UPON INSERTION IT WAS OBSERVED THAT ONE OF THE HAPTICS WAS AMPUTATED. THE IOL WAS THEN REMOVED AND A BACKUP IOL OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854350 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT WAS HAVING DIFFICULTY WITH READING VISION. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH NORMAL DAILY ACTIVITIES, INCLUDING NIGHT DRIVING. THE PRE-OPERATIVE TARGET REFRACTIVE VALUE WAS -0.25 AND THE FINAL REFRACTIVE VALUE POST-OPERATIVE WAS +-0.50. ADDITIONAL INFORMATION WAS RECEIVED STATING IOL EXPLANT IS SCHEDULED FOR (B)(6)2023. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING IOL EXPLANT WAS PERFORMED (B)(6)2023 AND THE IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES. PATIENT'S OUTCOME POST-LENS EXCHANGE WAS REPORTED AS LENSES IN GOOD POSITION AND PATIENT IS WELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 17243996 ↗