TECNIS IOL ZCT450 (REF ZCT450U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474602922), received between May 11, 2017 and Nov 11, 2019 — classified as 3 injuries, 2 malfunctions.

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.

• InjuryNov 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCT450 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 AS THE ASTIGMATISM CORRECTION WAS TOO MUCH, AND THE PATIENT EXPERIENCED DIPLOPIA AND AXIS FLIPPED. THE INITIAL IMPLANT OUTCOME SIGNIFICANTLY INTERFERED WITH THE PATIENT¿S ACTIVITIES OF DAILY LIFE PRIOR TO EXPLANT. MEASUREMENTS REPORTED 3D @085 PRE-OP X3, 2.5D @ 009 POST-OP. IT WAS INDICATED THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9303165 ↗
• InjuryAug 1, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT SURGEON WAS SCHEDULED FOR AN INTRAOCULAR LENS EXPLANT ON (B)(6) 2019 FROM PATIENT¿S RIGHT EYE. REPORTEDLY TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT450 17.0 DIOPTER) WAS PLACED IN THE RIGHT EYE AT AN AXIS OF 97 DEGREES ON (B)(6) 2019. POSTOP THE LENS HAD ROTATED AND REMAINED AT AN AXIS OF 125 DEGREES FOR 1 WEEK POSTOP. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT LENS WAS EXPLANTED ON (B)(6) 2019 AS PLANNED BECAUSE OF PATIENT EXPERIENCING UNEXPECTED POST OP REFRACTION, BLURRY VISION NOTED 2 WEEKS AFTER THE LENS INITIAL IMPLANT AND THE LENS HAD ROTATED 28 DEGREES. LENS WITH SAME MODEL AND HIGHER DIOPTER OF 18.5 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT HAS RECOVERED, AND THE EXPLANTED LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8853389 ↗
• MalfunctionMay 30, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A MODEL ZCT450 TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE, AND PLACED AT 90 DEGREES. AT THE 6TH MONTH POST-OP VISIT IT WAS NOTED THAT THE LENS ROTATED TO 70 DEGREES, A 20-DEGREE DIFFERENCE. NO SURGICAL ACTION OR TREATMENT IS PLANNED. THERE WAS NO REPORTED PATIENT COMPLICATION OR INJURY AND THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. CURRENT PATIENT STATUS IS NOTED AS THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655744 ↗
• MalfunctionOct 19, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WERE PARTICLES ON THE INTRAOCULAR LENS (IOL) OBSERVED PRIOR TO INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Information

  MAUDE report 6963869 ↗
• InjuryMay 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT450 17.0 DIOPTER WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE RESIDUAL REFRACTIVE ERROR. THE LENS WAS REPLACED WITH THE SAME MODEL LENS BUT A LOWER DIOPTER (16.0). THERE WERE NO COMPLICATIONS AND NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6562340 ↗