TECNIS IOL ZCT300 (REF ZCT300U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474553354), received between Feb 24, 2017 and May 19, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

• InjuryMay 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. THE IOL DISLOCATED. ADDITIONALLY, THE PATIENT EXPERIENCED CORNEAL EDEMA. THE REPLACEMENT LENS IS DIFFERENT JNJ MODEL ZA9003 25.0 DIOPTER. THE EXPLANTED IOL WILL NOT BE RETURNED AS IT WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 16968910 ↗
• InjuryOct 20, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A DOCTOR HAD TO EXCHANGE ONE TORIC INTRAOCULAR LENS FOR ANOTHER. THIS WAS DUE TO LENS ROTATED, AND IT WAS REPLACED WITH A MODEL ZCU300 22.5 DIOPTER LENS, BECAUSE HE WAS SLIGHTLY PLUS. IT WAS ALSO NOTED THAT THE EXCHANGE WENT WELL WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10708858 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE SURGEON HAD AN ISSUE WITH HIS INITIAL MEASUREMENTS USING THE OCULAR RESPONSE ANALYZER (ORA) AND THE POWER OF THE INTRAOCULAR LENS (IOL) WAS WAY OFF. THE PATIENT WANTED THE LENS REMOVED AND EXCHANGED. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING EXPLANT-EXCHANGE TOOK PLACE, AND THE INCISION WAS ENLARGED, HOWEVER, THERE WERE NO OTHER COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9650644 ↗
• MalfunctionAug 5, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 INTRAOCULAR LENS (IOL) WAS INVOLVED IN A CLINICAL STUDY. THE SUBJECT HAD THE LENS IMPLANTED AT 14 DEGREES, AND DURING THE 6 MONTH VISIT IT WAS AT 24 DEGREES. HOWEVER, THERE WAS NO REPOSITIONING IS PLANNED. THERE WAS NO PATIENT COMPLICATION OR INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8860456 ↗
• InjuryJul 18, 2017Crack; Crack

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZCT300 +21.5 DIOPTERS) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AS THE FEMALE PATIENT HAD POOR VISUAL ACUITY. REPORTEDLY, THE SURGEON NOTICED A CRACK IN THE EDGE OF THE IOL. ANOTHER LENS, SAME MODEL SMALLER DIOPTER (+19.0), WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6723443 ↗
• InjuryFeb 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF A ZCT300 21.5 DIOPTER INTRAOCULAR LENS (IOL), THE PATIENT'S ANTERIOR CHAMBER HAD RUPTURED. DUE TO THIS ISSUE, THE PHYSICIAN HAD TO USE A ZA9003 IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 6356745 ↗