TECNIS IOL ZCT400 (REF ZCT400U145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474553804), received between Mar 6, 2017 and Jun 10, 2020 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED THAT SHE HAD DOUBLE VISION IN BOTH EYES. HOWEVER, AFTER THE SURGERY IT ENABLED HER TO HAVE DOUBLE VISION IN ONE EYE (LEFT EYE). THE PATIENT CONFIRMED THAT THE PROBLEM IS ONLY WITH HER LEFT EYE. THE SURGERY HAS IMPROVED HER VISION; HOWEVER, THE PATIENT STILL CANNOT SEE. THE PATIENT INDICATED THAT SHE HAS A VERY BAD ASTIGMATISM AND HAS ALWAYS HAD NIGHT BLINDNESS. BUT AFTER THE SURGERY, THE ISSUE IS TWICE AS BAD, AND SHE HAS ZERO DEPTH PERCEPTION WHICH IS WHY SHE NO LONGER DRIVES AT NIGHT. WHEN THE PATIENT LOOKS AT A TRAFFIC LIGHT, SHE SEES ANOTHER TRAFFIC LIGHT JUST BELOW IT. THE LIGHTS AND STARBURST BOTHER THE PATIENT VERY MUCH, BUT SHE HAS BEEN USING A SPECIAL MIRROR DEVICE JUST FOR DRIVING WHICH HAS BEEN HELPING HER WITH THE LIGHTS. THE PATIENT REPORTED THAT SHE CANNOT READ A ROAD SIGN UNTIL SHE IS ABOUT TO PASS IT. SHE IS INVERTING NUMBERS, AND WHEN SHE LOOKS IN THE MIRROR HER PUPILS ARE DIFFERENT SIZES. THE PUPIL IN THE LEFT EYE IS LARGER THAN THE PUPIL IN THE RIGHT EYE. THE PATIENT ALSO HAD FLOATERS WHICH ARE GONE FOR THE MOST PART. THE PATIENT CORRECTED HERSELF THAT SHE NEVER HAD ANY PAIN AS WAS INITIALLY REPORTED, BUT JUST AN UNUSUAL FEELING. THE PAT

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 10136675 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT400 INTRAOCULAR LENS (IOL) WAS IMPLANTED AND THE PATIENT ENDED UP WITH 1.5 - 2 DIOPTER OF RESIDUAL CYLINDER. THE LENS WAS EXCHANGED WITH A ZCU600 IOL AND THE PATIENT WAS DOING FINE POST-OPERATIVELY. THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 9979322 ↗
• InjuryJul 31, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT400 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO VISUAL DISTURBANCE. THE SURGEON ALSO INDICATED THAT THE LENS ROTATED MORE THAN 30 DEGREE. ALTHOUGH THE SURGEON HAD TRIED TO ROTATE THE LENS BACK INTO PLACE, THE LENS DECENTERED AGAIN. THE PROCEDURE WAS COMPLETED WITH A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURE NEEDED. REPORTEDLY, PATIENT IS STABLE POST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 8845224 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT400 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE BECAUSE OF A VERY STRONG REFRACTIVE SURPRISE AND THE PATIENT NEEDED A STRONGER POWERED LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7062102 ↗
• MalfunctionMar 6, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE OF A (B)(6) FEMALE PATIENT. THE IOL, INITIALLY PLACED AT 61 DEGREES, WAS MEASURED AT SIX-MONTH VISIT AT 40 DEGREES, WITH A DIFFERENCE OF 21 DEGREES. REPORTEDLY, THE PATIENT HAD NO COMPLAINTS AT THE SIX-MONTH VISIT AND NO SECONDARY SURGICAL PROCEDURE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6383030 ↗