TECNIS IOL ZCT400 (REF ZCT400U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474553873), received between May 17, 2019 and May 17, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AT THE 1-DAY POST-OP VISIT, THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S RIGHT EYE, WAS OBSERVED TO HAVE ROTATED 24 DEGREES FROM THE INITIAL PLACEMENT OF 121 DEGREES TO 145 DEGREES. AT THE TIME OF THE POST-OP VISIT, THE PATIENT REPORTED BLURRY VISION AND FELT UNBALANCED. THE LENS WAS ROTATED, AND THE PATIENT REPORTED HIS VISION AS BEING GOOD. THERE WERE NO PATIENT INJURIES AND THE IOL REMAINED IMPLANTED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE IOL HAD ROTATED AGAIN. THE IOL WAS REPOSITIONED ROTATIONALLY A SECOND TIME. REQUESTS WERE MADE FOR SPECIFIC DETAILS ON THE SECOND ROTATION, BUT NO DETAILS HAVE BEEN PROVIDED. NO ADDITIONAL INFORMATION RECEIVED. THIS REPORT CAPTURES THE EVENT FOR THE SECOND ROTATION. THE INITIAL ROTATION IS BEING REPORTED IN A SEPARATE MDR.

  Patient problems: No Code Available

  MAUDE report 8621813 ↗
• InjuryMay 17, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AT THE 1-DAY POST-OP VISIT, THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S RIGHT EYE, WAS OBSERVED TO HAVE ROTATED 24 DEGREES FROM THE INITIAL PLACEMENT OF 121 DEGREES TO 145 DEGREES. AT THE TIME OF THE POST-OP VISIT, THE PATIENT REPORTED BLURRY VISION AND FELT UNBALANCED. THE LENS WAS ROTATED, AND THE PATIENT REPORTED HIS VISION AS BEING GOOD. THERE WERE NO PATIENT INJURIES AND THE IOL REMAINED IMPLANTED. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE IOL HAD ROTATED AGAIN. THE IOL WAS REPOSITIONED ROTATIONALLY A SECOND TIME. REQUESTS WERE MADE FOR SPECIFIC DETAILS ON THE SECOND ROTATION, BUT NO DETAILS HAVE BEEN PROVIDED. NO ADDITIONAL INFORMATION RECEIVED. THIS REPORT CAPTURES THE EVENT FOR THE INITIAL ROTATION. THE SECOND ROTATION IS BEING REPORTED IN A SEPARATE MDR.

  Patient problems: No Code Available

  MAUDE report 8621782 ↗