TECNIS IOL ZCT225 (REF ZCT225U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474552630), received between Jun 1, 2017 and Feb 20, 2018 — classified as 4 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 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.

• InjuryFeb 20, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT225 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. POST-OPERATIVELY, THE SAME DAY, THE LENS ROTATED ABOUT 33.5 DEGREES. THEREFORE, THE NEXT DAY AFTER SURGERY, THE DOCTOR ROTATED THE LENS BACK INTO IT'S ORIGINAL POSITION. A WEEK LATER, THE LENS WAS REPORTEDLY ROTATED AGAIN ABOUT 33.5 DEGREES, SO THE LENS WAS REPOSITIONED AGAIN SURGICALLY TO MOVE IT BACK TO IT'S ORIGINAL POSITION. REPORTEDLY, THE LENS ROTATED AND HAD TO BE REPOSITIONED A THIRD TIME. SINCE THIS THIRD PROCEDURE, THE LENS HAS NOT ROTATED AGAIN. HOWEVER, THE PATIENT COMPLAINED OF HALOS, GLARE, FLARES, AND A GRAYISH HAZE. THE PATIENT IS REPORTEDLY GOING TO HAVE A YTTRIUM-ALUMINUM GARNET (YAG) PROCEDURE ON (B)(6) 2018. THE PATIENT ALSO REPORTED THAT HER VISION IS EXCELLENT AND SHE IS SEEING 20/15 OUT OF THE OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7284759 ↗
• InjuryNov 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO POOR POST-OPERATIVE VISUAL OUTCOME. THE REPLACEMENT LENS WAS A ZCT300 14.0 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7026955 ↗
• InjuryAug 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE DUE TO REFRACTIVE ERROR WHICH WAS OBSERVED DURING POST-OP EXAMINATION. THE LENS WAS EXPLANTED AND REPLACED WITH A ZCT300 IOL WITH A LOWER DIOPTER (14.5). THERE WAS NO INJURY, NO COMPLICATIONS, NO INCISION ENLARGEMENT AND NO ADDITIONAL PROCEDURES WERE REQUIRED. THE SURGERY OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S DAILY ACTIVITIES. PATIENT HAS NOW RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6769886 ↗
• InjuryJun 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A MODEL ZCT225 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS INITIALLY EXPLANTED FROM A PATIENT¿S OPERATIVE EYE AS THE IOL IMPLANTED HAD A MECHANICAL COMPLICATION. FURTHER INFORMATION WAS PROVIDED AND IT WAS CLARIFIED THAT THE SURGEON AND PATIENT WERE NOT SATISFIED WITH THE VISUAL OUTCOME AS THE VISION HAD NOT IMPROVED. THE PATIENT REQUIRED A DIFFERENT IOL. A NON-AMO LENS WAS IMPLANTED AS THE REPLACEMENT LENS. THE SURGERY CENTER REPORTED THE PATIENT OUTCOME WAS IN GOOD CONDITION.

  Patient problems: No Code Available

  MAUDE report 6603777 ↗