TECNIS IOL ZCT225 (REF ZCT225U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474552784), received between Nov 13, 2017 and May 17, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE DOCTOR IS CONSIDERING EXPLANTING THE TECNIS TORIC INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT¿S RIGHT EYE AND THE TECNIS MONOFOCAL IMPLANTED IN THE LEFT EYE. THE PATIENT WAS COMPLAINING OF DEBILITATING FLICKERING FROM FLUORESCENT LIGHTS IN BOTH THE EYES. DOCTOR DID YAG (YTTRIUM-ALUMINUM-GARNET LASER) PROCEDURE FOR SOME SIGNIFICANT PCO (POSTERIOR CAPSULAR OPACIFICATION) IN THE LEFT EYE, BUT THIS DID NOT HELP. DOCTOR HAD TO REPOSITION THE TORIC IOL ONCE AND IT ROTATED AGAIN SECOND TIME. THE PATIENT IS POST LASER VISION CORRECTION IN BOTH EYES YEARS AGO. PATIENT DID NOT HAVE ANY SUCH DYSPHOTOPSIAS UNTIL AFTER IOL IMPLANTATION. ADDITIONAL INFORMATION WAS RECEIVED FOR RIGHT EYE AND IT WAS LEARNT THAT THE PATIENT HAS TROUBLE WITH FLUORESCENT LIGHTING BLINKING, IT¿S SOMETIMES IS BETTER WHEN PATIENT PUTS GLASSES ON. PATIENT HAS ALSO NOTICED THAT PROBLEMS HAVE STARTED WITH GLARE ESPECIALLY AT NIGHT. EXPLANT HAS NOT YET BEEN PERFORMED. THIS REPORT WILL COVER INFORMATION RELATED TO THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7524739 ↗
• MalfunctionMar 27, 2018Fracture; Fracture

  IT WAS REPORTED THAT A ZCT225 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT'S LEFT EYE (OS) BECAUSE THE LENS WAS NOTICED FRACTURED ONCE IMPLANTED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A BACK UP LENS OF THE SAME MODEL AND DIOPTER. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7373158 ↗
• InjuryJan 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT225 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) OF THE PATIENT ON (B)(4) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO POOR POST-OPERATIVE REFRACTION. THERE WAS NO INCISION ENLARGEMENT. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 17.0. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7229675 ↗
• InjuryNov 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017 INTO THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT COMPLAINED OF ONLY BEING ABLE TO SEE 6 INCHES AWAY. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT THE DIOPTER WAS UNABLE TO BE VERIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7025171 ↗