TECNIS IOL ZCT150 (REF ZCT150U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474552166), received between Oct 2, 2016 and Feb 19, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED WITH UNKNOWN REASON OF EXPLANT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 21417123 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT EYE DUE TO MYOPIA INTERFERING WITH ABILITY OF DRIVING. THERE WAS NO OTHER MEDICAL INTERVENTION AND THE PREVIOUS LASIK DID NOT CONTRIBUTE TO PATIENT BEING MYOPIC. THERE WAS NO OTHER MEDICAL HISTORY THAT LED TO THE ISSUE. THE PATIENT IS SOMEWHAT BETTER POST-OP. THE PROCEDURE WAS COMPLETED USING DIFFERENT LENS OF DIFFERENT DIOPTER POWER. NO FURTHER INFORMATION IS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10659758 ↗
• InjuryDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS, MODEL ZCT150 21.0 DIOPTER WAS EXPLANTED FROM THE RIGHT EYE (OD) OF A PATIENT DUE TO BLURRY VISION AND POST-OP REFRACTION AS THE PATIENT'S ASTIGMATISM WAS OVERCORRECTED. THE REPLACEMENT WAS A NON-JOHNSON & JOHNSON VISION LENS, 20.0 DIOPTER. REPORTEDLY, THE PATIENT HAS RECOVERED. IT WAS NOTED THAT THE LENS WAS DISCARDED AND WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9454805 ↗
• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT150, +21.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF THE PATIENT EXPERIENCING HALOS, GLARE, VISUAL DISTURBANCE, UNEXPECTED POST OP REFRACTION. PATIENT WAS UNABLE TO FOCUS, EXPERIENCED VISUAL DISTURBANCE WHILE DRIVING AT NIGHT. REPORTEDLY, A LENS MODEL ZCB00 +18.5 DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8081519 ↗
• InjuryOct 8, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT HAD UNEXPECTED POST-OP REFRACTION AFTER IMPLANTING MODEL ZCT150 TECNIS TORIC IOLS (INTRAOCULAR LENS) 21.0 DIOPTER (D) IN HER LEFT EYE (OS). HISTORICALLY, PATIENT HAD MYOPIC LASIK MANY YEARS AGO. IT SHOWED A HYPEROPIC PATTERN ON HER TOPOGRAPHY, AS REPORTED BY THE CUSTOMER. IT WAS ALSO LEARNT THAT SHE HAD HYPEROPIC TREATMENT FOR ENHANCEMENT. PREOPERATIVELY, PATIENT HAD 1.75 DIOPTERS WTR (WITH-THE-RULE) ASTIGMATISM. MODEL ZCT150 WAS IMPLANTED TARGETING 98 DEGREES ROTATION. POST-OPERATIVELY AT 1.5 WEEKS, IOL AXIS WAS DETERMINED TO BE AT 102 DEGREES. HOWEVER, REFRACTION SHOWED +0.50 -2.00 X 080, SO + CYL (CYLINDER) WAS DETERMINED TO BE AT 170 DEGREES. THE ACCOUNT COMMENTED THAT BASED ON (B)(6) SOFTWARE, BY ROTATING THE LENS 68 DEGREES COUNTER CLOCKWISE, WOULD RESOLVED THE CYLINDER. REPEAT TOPOGRAPHY POSTOPERATIVELY SHOWED 1.34 DIOPTER OF WTR ASTIGMATISM. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE DOCTOR IS PLANNING TO ROTATE THE LENS. IF AFTER REPOSITIONING OF THE LENS, THERE WILL STILL BE SIGNIFICANT RESIDUAL ASTIGMATISM, THEN THE SURGEON WILL EXCHANGE THE IOL FOR A MONOFOCAL LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Retinal Degeneration

  MAUDE report 7942484 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 21.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED BLURRY VISION AND WAS NOT ABLE TO SEE PAST FIVE FEET IN FRONT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZCB00 19.5 DIOPTER LENS. REPORTEDLY, THE PATIENT CAME OUT OKAY FROM SURGERY. NO ADDITIONAL INFORMATION.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 7847019 ↗
• InjuryApr 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7431647 ↗
• InjuryAug 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE DUE TO RESIDUAL REFRACTIVE ERROR WHICH WAS OBSERVED DURING POST-OP EXAMINATION. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A LOWER DIOPTER (20.0). THERE WAS NO INJURY, NO COMPLICATIONS, NO INCISION ENLARGEMENT AND NO ADDITIONAL PROCEDURES WERE REQUIRED. PATIENT HAS NOW RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6769915 ↗
• InjuryJul 18, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE LENS WAS IMPLANTED AND THEN EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. IT WAS REPORTED THAT THE LENS SUBLUXED AND FELL OUT OF PLACE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6723640 ↗
• InjuryJul 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150, TECNIS TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) DUE TO MECHANICAL COMPLICATION OF THE IOL. THE LENS WAS REPLACED WITH THE SAME MODEL, LOWER DIOPTER (20.0). THERE WAS NO INCISION ENLARGEMENT REQUIRED AND NO PATIENT INJURY REPORTED. IT WAS NOTED THAT LENS WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6723350 ↗
• InjuryMar 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SURGEON WAS PLANNING TO EXPLANT A TORIC INTRAOCULAR LENS (IOL) FROM THE RIGHT EYE OF A POST LASIK PATIENT WHO ENDED UP WITH POOR RESULTS/UNEXPECTED POST-OPERATION REFRACTION FOLLOWING CATARACT SURGERY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS, DIFFERENT MODEL ZCT400 AND SMALLER DIOPTRE +20.0. PRE-OP (BEFORE FIRST IMPLANTATION): OD (OCULUS DEXTER - RIGHT EYE): +1.25 -1.75 AT 70 DEGREES 20/25 GLARE 20/50. ONE-MONTH POST-OP (AFTER FIRST IMPLANTATION, BEFORE EXPLANT): OD: PLANO -2.25 AT 100 20/25. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6412092 ↗
• InjuryOct 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 INTRAOCULAR LENS WAS EXPLANTED IN A SECONDARY PROCEDURE DUE TO RESIDUAL REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT AND NO SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 5992896 ↗