TECNIS IOL ZCT450 (REF ZCT450U050)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474602687), received between Apr 6, 2018 and Apr 21, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED BY A PATIENT THAT THE INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED ON (B)(6) 2019, HAD ROTATED POST OP. SHE HAS A HIGH MYOPIA WITH 2.50 REGULAR ASTIGMATISM. SHE HAD AN UNCOMPLICATED CATARACT SURGERY WITH A TECNIS TORIC LENS ON HER RIGHT EYE. IMMEDIATELY ON POST-OP DAY ONE (1) HER VISION WAS TITLED TO RIGHT, AND SHE HAD FOUR (4) LINES OF DOUBLE VISION AND HER VISION WAS BARELY 20/60. SHE DID NOT KNOW/REMEMBER WHAT HER VISUAL ACUITY WAS PRE-OP. SHE HAS LONG EYES SO THIS MAY ALSO CONTRIBUTE TO THE ISSUE. SHE STATES SHE HAS NO NEAR VISION. SHE WAS BORN IN (B)(6), AND STILL WORKS. SHE NEEDS TO BE ABLE TO SEE TO WORK. THE IMPLANTING SURGEON WANTS TO DO A LASER PROCEDURE THIS FRIDAY AS THAT IS WHAT THE DOCTOR PREFERS TO DO. PATIENT RELAYED THAT SHE DOES NOT THINK THIS IS HER BEST CHOICE AND WANTED SUGGESTIONS. REPORTEDLY, THE LENS ROTATED FROM THE TARGET AXIS OF 92 DEGREES TO 42 DEGREES. HER ASTIGMATISM INCREASED FROM 2.5 TO 4.0; THE MACHINE READ 5.0. HER DOCTOR WAS UNABLE TO PROVIDE THE UNDERLYING REASON AND HAS OFFERED TO FIX IT BY LENS XXX OR BY LASIK SURGERY.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 8534444 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CAPSULAR BAG TORE AFTER A ZCT450 5.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS). THE LENS WAS THEN CUT, REMOVED FROM THE OPERATIVE EYE, AND REPLACED WITH ANOTHER MANUFACTURERS LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THERE WAS NO MEDICAL INTERVENTION OUTSIDE OF THE ROUTINE POST-OPERATIVE MANAGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7404284 ↗