TECNIS IOL ZCT150 (REF ZCT150U255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474552258), received between Apr 26, 2017 and Oct 20, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2019Adverse 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. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE BUT NO RESPONSE HAS BEEN PROVIDED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available; No Patient Involvement

  MAUDE report 9212497 ↗
• MalfunctionNov 1, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT A ZCT150 25.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED, REMOVED AND REPLACED IN THE SAME SURGICAL PROCEDURE AS A SCRATCH WAS OBSERVED ON THE LENS AFTER INSERTION. REPORTEDLY ANOTHER LENS OF THE SAME MODEL AND SAME DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE AND NO VITRECTOMY PERFORMED. PATIENT WAS REPORTED TO BE DOING FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8031515 ↗
• InjurySep 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL), MODEL ZCT150 (25.5 DIOPTER) WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE (OD) DUE TO VISUAL DISTURBANCE WHICH SIGNIFICANTLY INTERFERED WITH PATIENT'S DAILY LIFE ACTIVITIES. A REPLACEMENT LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (25.0) WAS USED. THERE WAS NO INCISION ENLARGEMENT AND IT WAS INDICATED THAT THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6854337 ↗
• MalfunctionApr 26, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE CARTRIDGE TIP WAS OBSERVED BROKEN/CRACKED. REPORTEDLY, THE LENS WAS PARTIALLY INSERTED IN THE EYE AND THEN REMOVED. THE SURGEON DID NOT WANT TO ADVANCE THE LENS ANY FURTHER TO PREVENT POSSIBLE SCRATCHES ON THE LENS. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE LENS WAS SCRATCHED. REPORTEDLY, THE INCISION WAS NOT ENLARGED AND THE PATIENT WAS REPORTED AS HAVING RECOVERED. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR IS TO RECORD THE LENS. A SEPARATE REPORT HAS BEEN SUBMITTED FOR THE CARTRIDGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6521302 ↗