TECNIS IOL ZCT450 (REF ZCT450U125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474602830), received between Apr 3, 2017 and Apr 3, 2019 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO UNDEFINED MECHANICAL COMPLICATIONS, REFRACTIVE ERROR. THE LENS WAS REPLACED WITH A DIFFERENT TORIC MODEL LENS OF A LOWER DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8481250 ↗
• MalfunctionJul 6, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE TECNIS TORIC ZCT450 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS NOTED THAT THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. PROCEDURE WAS SUCCESSFULLY COMPLETED. REPORTEDLY, THE LENS WAS PLACED AT 80 DEGREES AND IT WAS MEASURED, AT THE 6-MONTH VISIT ON (B)(6) 2018, AT 70 DEGREES. PATIENT OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE LENS REMAINS IMPLANTED AND NO IOL REPOSITIONING WAS PERFORMED OR PLANNED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7665896 ↗
• MalfunctionApr 3, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) FEMALE PATIENT. THE IOL, INITIALLY PLACED AT 80 DEGREES ON (B)(6) 2016, WAS MEASURED AT 70 DEGREES ON (B)(6) 2017, WITH A DIFFERENCE OF 10 DEGREES. REPORTEDLY, THERE WERE NO PATIENT OR DOCTOR COMPLAINTS AND THE BCDVA (BEST-CORRECTED DISTANCE VISUAL ACUITY) WAS 20/20 ON BOTH EYES. A TECNIS TORIC ROTATION, FOR THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE, WAS ALSO REPORTED. A SECOND MDR WILL BE FILED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6455380 ↗