TECNIS IOL ZCU150 (REF ZCU150U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474657830), received between Aug 26, 2020 and Oct 29, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON-PRELOADED TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DURING A SECONDARY SURGERY BECAUSE THE PATIENT EXPERIENCED DYSPHOTOPSIA. THE ORIGINAL LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON IOL. NO COMPLICATIONS OCCURRED DURING THE REPLACEMENT SURGERY AND THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. THE PATIENT STATUS IS UNKNOWN. IT WAS REPORTED THAT THERE WERE NO PRODUCT QUALITY ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 23415976 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BLURRY VISION IN BOTH EYES (OU) RESULTING FOR THE NEED TO EXPLANT BOTH INTRAOCULAR LENSES (IOLS). THE IOLS WERE EXPLANTED ON SEPARATE DAYS AND REPLACED WITH NON-JOHNSON & JOHNSON IOLS. THE INCISION WAS ENLARGED. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE LEFT EYE (OS). A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE (OD).

  Patient problems: Blurred Vision

  MAUDE report 14691791 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO WAS STATUS POST (S/P) RADIAL KERATOTOMY (RK) & LASER VISION CORRECTION (LVC), UNDERWENT AN INTRAOCULAR LENS (IOL) EXPLANT ON THE RIGHT EYE DUE TO POOR POST-OP RESULT. THE PATIENT¿S SYMPTOM WAS NOTICED 1-DAY POST OPERATION. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER, ZCU225 (+20.0 D) WAS USED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME POST-OP WAS REPORTED TO BE 20/40 AT 1-DAY PO STILL FOLLOWING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12047331 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS TORIC INTRAOCULAR LENS (IOL) WAS OPENED AND ABOUT TO BE IMPLANTED, BUT THE PATIENT'S CAPSULE RUPTURED WHERE AN EMERGENCY VITRECTOMY WAS PERFORMED. THE LENS WAS WASTED AND NOTHING IS COMING BACK. A BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11598899 ↗
• MalfunctionMar 2, 2021Use of Device Problem; Inaccurate Delivery; Difficult to Advance; Use of Device Problem; Inaccurate Delivery; Difficult to Advance

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD LOADING ISSUE AND THE LENS INJECTED WHEN INJECTOR WAS ONLY PARTIALLY INSERTED IN THE PATIENT'S LEFT EYE. THE LENS WAS PARTIALLY INSERTED AND WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL. THE EVENT WAS OBSERVED WHILE INSERTING INTO THE EYE. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11398608 ↗
• InjuryAug 26, 2020Adverse 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 FROM A PATIENT¿S LEFT EYE DUE TO POWER SURPRISE. IT WAS LEARNED THAT THE PATIENT WAS +22 THEN POST-OP +3.75. THERE WERE NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. THERE WAS NO PATIENT POST-OP INJURY. THE REPLACEMENT LENS IS THE SAME MODEL, BUT HIGHER DIOPTER (27.5). NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10452474 ↗