TECNIS IOL ZCT400 (REF ZCT400U255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474554023), received between Feb 20, 2017 and Jun 15, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2017Inadequacy of Device Shape and/or Size; Unintended Movement; Inadequacy of Device Shape and/or Size; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (MODEL ZCT400, +25.5 DIOPTERS) WAS IMPLANTED IN THE EYE OF A MALE PATIENT. REPORTEDLY, TOGETHER WITH THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL), A DSAEK SURGERY (DESCEMETS STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY) WAS PERFORMED. THERE WAS NO TRAUMA OR INJURY TO THE PATIENT'S EYE AFTER THE PROCEDURE. AFTER THE CORNEA TRANSPLANT HAD CLEARED, IT WAS NOTICED THAT IOL HAD ROTATED AND THE AXIS WAS OFF. ALSO THE SPHERICAL POWER WAS NOTICED TO BE OFF. THE SURGEON HAD USED THE ORA (OCULAR RESPONSE ANALYSER) AND HAD VERIFIED THE PROPER AXIS ORIENTATION. THE IOL WAS THEN EXPLANTED AND REPLACED, WITHOUT COMPLICATIONS, WITH ANOTHER LENS, SAME MODEL SMALLER DIOPTER +23.5. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED. ONE CORNEAL SUTURE WAS USED AT THE MAIN WOUND. POST-OP ONE DAY AFTER IOL EXCHANGE, UNCORRECTED VA (VISUAL ACUITY) IMPROVED TO 20/40 FROM 20/200. ADDITIONAL INFORMATION WAS RECEIVED AND THE PATIENT WAS REPORTED DOING GREAT AND HAPPY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6642592 ↗
• InjuryFeb 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT CONTACTED ABBOTT MEDICAL OPTICS TO REPORT THAT HE HAD LENSES IMPLANTED (B)(6) 2016, IN HIS RIGHT EYE AND THEN HIS LEFT EYE. PATIENT REPORTS HE HAS NOT BEEN HAPPY WITH THE LENSES. HE REPORTS HIS VISION IS WORST IN THE LEFT EYE BUT BAD ENOUGH IN THE RIGHT EYE TO BE A PROBLEM WHEN DRIVING AT NIGHT. HE INDICATED THAT HIS DOCTOR TOLD HIM HE HAS TO LIVE WITH IT, BUT PATIENT STATED HE IS NOT SATISFIED WITH THAT ANSWER. A CALL WAS MADE TO THE PATIENT WHO REPORTED HE IS SEEING STREAKS/SPIKES OF LIGHT MOSTLY IN THE LEFT EYE BUT ALSO A BIT ON THE RIGHT EYE. HEADLIGHTS ARE AN ISSUE. DRIVING AT NIGHT IS DIFFICULT; ONE HEADLIGHT APPEARS AS THREE. DAYTIME IS FINE. HAS SEEN HIS DOCTOR TWICE ((B)(6)) AND WAS TOLD HE HAS TO LIVE WITH IT AND SHOULD CONSIDER NOT DRIVING AT NIGHT. VISION WAS 20/15 IN THE RIGHT EYE FOLLOWING INITIAL SURGERY, BUT AFTER THE SECOND SURGERY THE VISION IS NOT NEARLY AS CLEAR. HE DOES NOT KNOW HIS CURRENT VISION BUT THE PRESCRIPTION ON HIS NEW GLASSES FOR THE RIGHT EYE IS SPHERE -.25, CYLINDER .50, AXIS 005; LEFT EYE SPHERE -.75, CYLINDER 1.50, AXIS 135. THE PATIENT HAS NOT RECEIVED HIS NEW GLASSES YET. IT WAS SUGGESTED TO THE PATIENT THAT HE MAY WANT TO SEEK A SECO

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6344431 ↗