TECNIS IOL ZCU300 (REF ZCU300U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474660168), received between Mar 2, 2021 and Jun 2, 2023 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionJun 2, 2023Break; Break

  IT WAS REPORTED THE PLUNGER OF THE LOADER MADE A HOLE IN THE ZCU300 MODEL INTRAOCULAR LENS (IOL) UPON INSERTION. THE IOL WAS FULLY INSERTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DURING THE SAME PROCEDURE, THE IOL WAS REMOVED AND REPLACED, WITH ANOTHER ZCU300 20.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT STATUS POST-PROCEDURE IN UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052288 ↗
• InjuryMar 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A TECNIS TORIC II INTRAOCULAR LENS (IOL) HAD MECHANICAL ISSUES DUE TO INCORRECT DIOPTER USED. THE LENS WAS LATER EXPLANTED AND REPLACED WITH A MODEL ZCU375, 21.0 DIOPTER IOL. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED AND NO INJURY WAS REPORTED. REPORTEDLY, THE PATIENT IS DOING GOOD POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448345 ↗
• InjuryMar 2, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR WAS NOT HAPPY UPON THE INSERTION OF THE INTRAOCULAR LENS (IOL). THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A BACKUP LENS OF THE SAME MODEL AND DIOPTER. THE EVENT WAS OBSERVED WHEN INSERTING INTO THE EYE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398395 ↗