TECNIS IOL ZCT150 (REF ZCT150U265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474552272), received between Dec 1, 2016 and Aug 10, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENSES (IOLS) WERE IMPLANTED, THE PATIENT IS EXPERIENCING HALOS IN BOTH EYES (OU) AND IS HAVING DIFFICULTY DRIVING AT NIGHT. THE PATIENT STILL DRIVES AT NIGHT BUT IS UNCOMFORTABLE. THE PATIENT REPORTED THAT READING SIGNS IS MORE DIFFICULT NOW AND NOT AS CLEAR AS RIGHT AFTER THE SURGERY. THE ISSUE HAS GOTTEN WORSE OVER TIME, AND NOW THE PATIENT CAN HARDLY READ STREET SIGNS. THE PATIENT HAS NOT STOPPED DOING DAILY ACTIVITIES, BUT JUST FINDS IT A LOT MORE DIFFICULT BECAUSE OF THE VISUAL ISSUES. THE PATIENT HAS NOT TRIED TO WEAR GLASSES AND STATED THAT THE DOCTOR HAS NOT RECOMMENDED IT. THE ISSUE STARTED OU A FEW MONTHS AGO. THE PATIENT COULD NOT PROVIDE AN EXACT DATE. THE DOCTOR IS RECOMMENDING A ¿LASER PROCEDURE¿ WHICH IS SUPPOSED TO HELP WITH THE VISUAL ISSUES, WHICH HAS NOT BEEN SCHEDULED YET. THE PATIENT REPORTED THAT THE DOCTOR ADVISED THAT THE MEMBRANE GREW BACK AND ¿COVERED IT¿, WHICH IS WHY THE ¿LASER PROCEDURE¿ IS REQUIRED. THROUGH FOLLOW-UP WITH THE DOCTOR¿S OFFICE, IT WAS REPORTED THAT THE PATIENT HAS POSTERIOR CAPSULAR OPACIFICATION (PCO) OU AND HAS YTTRIUM ALUMINUM GARNET (YAG) LASER PROCEDURE SCHEDULED OU. THE LEFT EYE (OS) YAG

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Halo

  MAUDE report 15203358 ↗
• InjurySep 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 LENS 26.5 DIOPTER LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE AS THE PATIENT REQUESTED TO SEE FARTHER AWAY. NO MORE INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8973452 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150 26.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING UNEXPECTED POST OP REFRACTION WHICH SIGNIFICANTLY AFFECTED DAILY ACTIVITIES. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. A MODEL ZCT225 11.5 DIOPTER LENS WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS NOTED AS RECOVERED POST-EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8201942 ↗
• InjuryMay 7, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150, +26.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT IMMEDIATELY EXPERIENCING POOR DISTANCE VISION DUE TO MYOPIC OUTCOME OF -1.50D. PATIENT WAS STATUS POST -OP HYPEROPIC AND HAD UNDERWENT LASIK PRIOR TO CATARACT SURGERY. DURING THE EXPLANT PROCEDURE AND INCISION ENLARGEMENT WAS REQUIRED AND TWO SUTURES WERE USED TO CLOSE THE INCISION. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZCT150, +24.5 DIOPTER IOL. PATIENT WAS REPORTED TO BE DOING GOOD AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7491867 ↗
• InjuryDec 1, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 26.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A FEMALE'S PATIENT LEFT EYE DUE TO MYOPIC OUTCOME, BLURRY VISION AND DIFFICULTY IN DRIVING. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. THE LENS WAS REPLACED WITH THE SAME MODEL LENS OF A LOWER DIOPTER (24.5). THERE WAS NO PATIENT POST-OP INJURY AND THAT SURGERY WENT WELL.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6137390 ↗