TECNIS IOL ZCU300 (REF ZCU300U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474660229), received between Aug 14, 2020 and Jun 3, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT NON PRELOADED TORIC II INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD). IT WAS NOTED THAT THERE WAS NO PRODUCT ISSUE. HOWEVER, IT WAS LEARNT THAT THE LENS WAS REPLACED WITH NON JOHNSON AND JOHNSON LIGHT ADJUSTABLE LENSES PER PATIENT'S REQUEST. THE PATIENT IS DOING WELL. THERE WAS NO PATIENT INJURY. PATIENT IS NOT EXPERIENCING ANY ISSUES AT THIS TIME. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 19455719 ↗
• InjuryOct 21, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE ACCOUNT REPORTED OF A VERY BIG POST-OP SURPRISE ON THE RIGHT EYE OF A PATIENT THAT WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL). THE PATIENT IS A IS POST MYOPIC (RK) RADIAL KERATOTOMY (8-CUTS) WHO WAS IMPLANTED BASED ON BARRET POST RK FORMULA TARGETING +0.12. 3-WEEKS POST-OP MANIFEST REFRACTION (MRX) +3.25 SPHERE (SPH) 20/20. THE PATIENT WAS VERY UNHAPPY AND WANTED TO HAVE CORRECTIVE SURGERY AS SOON AS POSSIBLE. THE DOCTOR WAS CONCERN ABOUT THE POWER OF THE LENS. THE DATE THAT THE UNEXPECTED POS-OP REFRACTION ISSUE FIRST NOTICED WAS INDICATED TO BE ON (B)(6) 2021; ALSO CONFIRMED ON (B)(6) 2021. THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE ON (B)(6) 2021 AS SCHEDULED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT LENS, MODEL DIU375, 27.5 DIOPTER POSITIONED AT 040. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED AND PATIENT OUTCOME POST-OPERATIVE DAY-1 (POD1), UNCORRECTED VISUAL ACUITY (UCVA) WAS REPORTED TO BE 20/20-2. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Visual Impairment

  MAUDE report 12670314 ↗
• MalfunctionAug 14, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A SEVERE ROTATION OF 30 DEGREES. THE LENS WAS NOT EXPLANTED. A VITRECTOMY WAS NOT PERFORMED AND NO UNUSUAL SITUATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10411172 ↗