TECNIS IOL ZCT150 (REF ZCT150U240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474552227), received between Dec 11, 2016 and Apr 14, 2022 — classified as 3 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 14, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) AND A SCRATCH ON THE LENS WAS IDENTIFIED AFTER LENS IMPLANTATION. THE IOL WAS REMOVED DURING THE SAME PROCEDURE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACK-UP LENS WITH THE SAME MODEL AND DIOPTER SIZE. THERE WAS NO UNPLANNED VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116499 ↗
• MalfunctionJul 23, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING THE 1-DAY POST-OPERATIVE EXAMINATION, THE INTRAOCULAR LENS (IOL) WAS OBSERVED TO HAVE ROTATED 12-15 DEGREES. THE IOL REMAINS IMPLANTED AND NO INTERVENTION HAS BEEN PLANNED OR PERFORMED. NO ADDITIONAL INFORMATION WAS RECEIVED. PRE-OPERATIVE VISUAL ACUITY: 20/40 WITH CONTRAST OF 20/70. POST-OPERATIVE VISUAL ACUITY: 20/40 AT 1 DAY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8815879 ↗
• InjuryOct 13, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO AN UNEXPECTED POST-OPERATIVE REFRACTION AND THE LENS BEING THE INCORRECT POWER AS THE PATIENT HAD A LASER VISION AND ENHANCEMENT PROCEDURE PERFORMED. THERE WAS AN INCISION ENLARGEMENT PERFORMED AND SUTURE(S) WERE USED. NO VITRECTOMY WAS PERFORMED. REPORTEDLY, THERE WAS NO SERIOUS PATIENT INJURY. LENS REPLACED WITH THE SAME MODEL, A SMALLER, 21.0 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6950356 ↗
• InjuryJul 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IT HAS BEEN OVER ONE (1) YEAR THAT THE PATIENT HAS BEEN HAVING ISSUES WITH BOTH EYES. IT WAS REPORTED THAT A MALE PATIENT HAS BEEN SUFFERING FOR OVER ONE (1) YEAR. WITH ONE EYE HE CAN SEE VERY CLOSE AND WITH THE OTHER EYE HE CAN ONLY SEE FAR AWAY AND THAT HE CANNOT READ WITH EITHER EYES. IT WAS REPORTED THAT THE PATIENT IS UNBALANCED WHEN HE LOOKS THROUGH BOTH EYES. THE PATIENT VISITED HIS DOCTOR AND WAS GIVEN PRESCRIPTION GLASSES WHICH HAS NOT HELP HIM AT ALL. THE PATIENT HAS DIFFICULTY DRIVING AND GETS DIZZY AS THERE IS NO BALANCE. THE PATIENT SAW ANOTHER DOCTOR WHO CONFIRMED THE FIRST DOCTOR¿S DIAGNOSIS, THAT HE WOULD NEED GLASSES. BOTH DOCTORS INFORMED THE PATIENT THAT THERE IS NO PLAN TO EXPLANT THE LENSES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO PATIENT'S LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S RIGHT EYE (OD).

  Patient problems: Dizziness; Visual Disturbances

  MAUDE report 6753226 ↗
• InjuryDec 11, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS AIMING FOR A -2.00 OR -2.25 MONO VISION ON PATIENT'S LEFT EYE HOWEVER THE IMPLANT RESULTED IN -4.25+150 CYLINDER X 127. THE TORIC INTRAOCULAR LENS (IOL) IN THE RIGHT EYE CAME OUT GREAT WITH -0.5+0.75 X052. THE PATIENT IS STATUS POST LASIK IN BOTH EYES. THE ORA (OCULAR RESPONSE ANALYZER) WAS USED FOR BOTH CASES. THE PHYSICIAN IS PLANNING ON DOING A TORIC MULTIFOCAL EXCHANGE IN THE LEFT EYE (OS) DUE TO PATIENT EXPERIENCING BLURRY AND HAZY VISION AND HAS ISSUES WITH HER DISTANCE AND NEAR VISION AND HER READING IS AFFECTED. SECONDARY ISSUES NOTED AS DRY EYE SYNDROME, OCULAR HISTOPLASMOSIS AND OCULAR MIGRAINE.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances

  MAUDE report 6165004 ↗