TECNIS IOL ZCT150 (REF ZCT150U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474552043), received between Mar 30, 2017 and Nov 8, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN INTRAOCULAR LENS (IOL) IN THEIR RIGHT EYE WAS HAVING BLURRED VISION. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT STARTED HAVING BLURRY VISION ABOUT 2 MONTHS AGO. THE PATIENT CONFIRMED HER VISUAL ISSUE IS NOT DEBILITATING, BUT MORE OF AN ANNOYANCE. THE PATIENT HAS ONLY RECEIVED GLASSES IN JANUARY. NO OTHER TREATMENT REPORTED. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT SAW HER DOCTOR ON (B)(6) 2022 AND THE DOCTOR TOLD HER THERE IS A BUBBLE BEHIND THE LENS AND SAID IT WAS NORMAL. THE PATIENT WENT BACK TO SEE HER DOCTOR ON (B)(6) 2022 TO REMOVE THE BUBBLE. SHE SAID THE DOCTOR LASERED HER EYE. THE PATIENT'S VISION WAS IMMEDIATELY MUCH BETTER AND THE PATIENT IS HAPPY NOW. THE PATIENT DID NOT KNOW THE NAME OF THE BUBBLE, BUT SAID IT IS ON HER PAPERWORK THAT SHE THREW AWAY. THE PATIENT CONFIRMED THE SURGEON PERFORMED A YTTRIUM ALUMINUM GARNET (YAG) CAPSULOTOMY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 15756250 ↗
• MalfunctionDec 6, 2018Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A ZCT150 15.0 DIOPTER LENS WAS DAMAGED WHEN INSERTING INTO THE PATIENT'S LEFT EYE (OS). THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER. IT WAS ALSO REPORTED THAT THE LENS MAY HAVE BEEN LOADED POORLY. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WERE NO PATIENT PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8140078 ↗
• InjuryOct 7, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED ON (B)(6) 2017, BECAUSE IT WAS THE INCORRECT POWER LENS FOR THE PATIENT. REPORTEDLY, THE DOCTOR PLANNED TO REPLACE THE LENS WITH THE SAME MODEL, BUT A DIFFERENT 17.0 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6927347 ↗
• InjuryMar 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6447397 ↗