TECNIS IOL ZCT450 (REF ZCT450U120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474602823), received between Nov 2, 2016 and Nov 28, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (3 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.

• InjuryNov 28, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT450 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. IN ONE WEEK POST OP APPOINTMENT HE WAS INFORMED THAT LENS WAS NOT AT THE RIGHT ANGLE. IT WAS NOTED THAT THE PATIENT HAS HIS 8TH WEEK APPOINTMENT SOON, AND HE WANTS TO GATHER THE CORRECT QUESTIONS TO ASK THE DR. WHEN HE MEETS WITH HIM. HE IS CURIOUS ABOUT WHAT THE STATISTICS ARE ABOUT PERCENTAGE OF LENSES THAT NEED ROTATION ADJUSTMENTS. IT WAS LEARNED THAT THE PATIENT¿S RIGHT EYE HAS BEEN BLURRY SINCE POST-OP BUT HAD NEVER IMPROVED OR EVEN GOTTEN WORSE AND WHEN THE DOCTOR CHECKED HIM ONE WEEK POST-OP THAT'S WHEN THEY FOUND OUT THAT HIS LENS MOVED. THE DOCTOR HAS MENTIONED TO HIM ABOUT LENS REPOSITION BUT PATIENT IS CONCERNED OF COMPLICATIONS HENCE HE CALLED FOR SOME ADVISE. FURTHER FOLLOW-UP WITH THE DOCTOR CONFIRMED THAT THE TORIC IOL HAS MOVED APPROXIMATELY 40 DEGREES FROM INTENDED POSITION. THE DOCTOR OFFERED TO MOVE THE LENS IMPLANT BUT THE PATIENT DECLINED TO HAVE FURTHER SURGERY. BECAUSE HE IS GOING TO HAVE TO WEAR GLASSES TO CORRECT THE FELLOW EYE TO 20/20, THE PATIENT CHOSE TO JUST LEAVE THINGS ALONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 9388382 ↗
• InjuryMay 3, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT450 12.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO THE LENS ROTATING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6541242 ↗
• MalfunctionNov 2, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) MALE PATIENT. THE IOL, INITIALLY PLACED AT 90 DEGREES, WAS MEASURED AT SIX-MONTH VISIT AT 79 DEGREES. REPORTEDLY, NEITHER THE SURGEON OR THE PATIENT HAD ANY COMPLAINTS AT THE SIX-MONTH VISIT. THE LENS REMAINED IMPLANTED AND THE BCDVA (BEST CORRECTED DISTANCE VISUAL ACUITY) WAS 20/20. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6073681 ↗