TECNIS IOL ZCT150 (REF ZCT150U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474552142), received between Sep 9, 2016 and Jul 1, 2021 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS (IOL) ROTATED IN THE PATIENT'S LEFT EYE FROM 26 DEGREES TO 75 DEGREES ON 1 DAY POST OPERATIVE VISIT AND WAS AT 72 DEGREES DURING THE 6TH DAY VISIT. THE LENS WAS ON AXIS WHEN THE PATIENT LEFT THE OPERATING ROOM. THE PATIENT HAD BLURRY VISION DUE TO THE ROTATION. THERE WAS NO OTHER PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE LENS WAS EXPLANTED AND ANOTHER LENS OF DIFFERENT MODEL SN_(B)(4) WAS PLACED AS THE REPLACEMENT. NO COMPLICATION OCCURRED DURING THE EXPLANT PROCEDURE. A CAPSULAR TENSION RING WAS ALSO INSERTED AS WELL. PATIENT WAS DOING WELL AFTER THE EXPLANT AND HAD 20/20-1 VISION AT POST-EXPLANT DAY 1. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12104912 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE IN SECONDARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNED THAT WRONG DIOPTER LENS WAS IMPLANTED INITIALLY WHICH WAS NOTED IN POST OP VISIT. THE LENS WAS EXPLANTED AND REPLACED WITH CORRECT LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10287552 ↗
• InjuryFeb 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZCT150 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2020. THE ZCT150 20.0 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO COMPLAINTS OF PATIENT NOT SEEING CLEARLY AND REPLACED WITH A ZCT150 21.5 DIOPTER LENS. IT WAS REPORTED THERE WAS NO PATIENT INJURY AND THE PATIENT WAS REPORTED AS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9760835 ↗
• InjuryJan 23, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT¿S VISION HAS BEEN BAD SINCE SURGERY IN (B)(6) 2017, RECENTLY WAS TOLD BY HIS HEALTHCARE PROVIDER THAT HE HAS ASTIGMATISM IN HIS LEFT EYE WHEN HE THOUGHT IT SHOULD HAVE BEEN FIXED WITH THE SURGERY, HE CAN¿T GET EYE GLASSES BECAUSE HIS PRESCRIPTION KEEPS CHANGING AND IS NOT HAPPY WITH THE LENSES. REPORTEDLY HE WAS RECOMMENDED TO USE READING GLASSES. HE ASSUMES THAT HIS LENS MAY HAVE SHIFTED. PATIENT IS EXPERIENCING SCATTERED LIGHT, HALOS, STARBURSTS, DOUBLE VISION ESPECIALLY AT NIGHT. HE CAN SEE OF ABOUT 4 FEET AWAY, ANYTHING CLOSER IS BLURRY, HE CAN WATCH TELEVISION OK, HE CANNOT READ A BOOK, HE CAN USE HIS IPAD, BUT NEEDS TO ZOOM ALL THE WAY IN TO SEE IT. HE REALLY NEEDS GLASSES, BUT WITH HIS PRESCRIPTION CONSTANTLY CHANGING HE CAN¿T AFFORD TO BUY NEW GLASSES EVERY TIME. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT HIS ASTIGMATISM WAS NEVER RESOLVED, AND HIS DAILY ACTIVITIES ARE ISSUE AND HIS NIGHT VISION IS TERRIBLE. PATIENT THINKS THAT HIS LENS IN BOTH EYES HAS ROTATED DUE TO WHICH HE IS HAVING THIS ISSUE. PATIENT REPORTED THAT VISUAL ACUITY ISSUE WAS RIGHT AWAY AFTER THE SURGERY AND HAD BECOME WORSE AFTER THE LEFT EYE SURGERY. THIS EVE

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 9619873 ↗
• InjuryOct 16, 2019Unintended Movement; Unintended Movement

  IT WAS INITIALLY REPORTED THAT A MODEL ZCT150 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE LENS WAS THE WRONG DIOPTER AND SIZE. HOWEVER, ADDITIONAL INFORMATION WAS PROVIDED, AND IT WAS LEARNED THE PATIENT EXPERIENCED BLURRY VISION, HYPEROPIC SURPRISE, AND THE LENS ROTATED GREATER THAN 10 DEGREES POST-OPERATIVELY. AT EXPLANT/EXCHANGE THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT HAD PREVIOUSLY UNDERGONE A LASIK PROCEDURE. THE PATIENT¿S VISUAL ACUITY (VA) WAS 20/30. POST-OP VA WAS 20/40. THE REPLACEMENT LENS IS THE SAME MODEL BUT A HIGHER DIOPTER (22.0). NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Impairment

  MAUDE report 9199234 ↗
• MalfunctionApr 8, 2019Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS WOULD NOT UNFOLD WHEN INSERTING INTO THE EYE. THEREFORE, THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8493302 ↗
• InjuryMar 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL ZCB00 24.5 DIOPTER INTRAOCULAR LENS. THERE WAS AN INCISION ENLARGEMENT PERFORMED. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8427188 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZCT150 +20.0 DIOPTER) WAS IMPLANTED INTO THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. ONE DAY POST-OP IT WAS NOTED A REFRACTIVE MISS AND THE SURGEON PLANNED TO EXCHANGE THE LENS ON (B)(6) 2018. VISUAL ACUITY PRE-OPERATIVE: UNCORRECTED 20/200. REFRACTION: -15 + 0.75, 165 DEGREES; CORRECTED 20/25. VISUAL ACUITY POST-OPERATIVE: UNCORRECTED 20/80. REFRACTION: -1.5 + 0.25, 10 DEGREES; CORRECTED 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7826212 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED DUE TO UNKNOWN REASONS AND REPLACED WITH A ZCT400 20.5 DIOPTER LENS ON (B)(6) 2018. THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7254631 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IMPLANTED IN THE LEFT EYE OF A MALE PATIENT ON (B)(6) 2017, WAS PLANNED TO BE EXPLANTED. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7073547 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE BECAUSE THE PATIENT WAS MORE HYPEROPIC THAN THE DOCTOR ANTICIPATED. THE REPLACEMENT LENS WAS A HIGHER POWERED LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7062050 ↗
• InjuryJun 20, 2017Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED AS THE HAPTIC TORE THE CAPSULE BAG. FURTHER INFORMATION REPORTED THE EVENT OCCURRED DUE TO LOADING ERROR WITH THE LENS. THE LENS WAS REPLACED WITHIN THE SAME PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 6655451 ↗
• InjuryOct 21, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNEXPECTED POST OP REFRACTION. PATIENT REQUIRED A HIGHER POWER LENS. REPLACEMENT LENS WAS 22.5 DIOPTER; THE EXPLANTED LENS WAS 20.0 DIOPTER. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 6046224 ↗
• InjurySep 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZCT150 INTRAOCULAR LENS (IOL) IN BOTH EYES, THE PATIENT EXPERIENCED GREAT DEAL OF TROUBLE UNDER FLUORESCENT LIGHTING. PATIENT IS HAVING HARD TIME WORKING ON THE COMPUTER, IS UNCOMFORTABLE AND HAS TROUBLE SEEING, FOCUSING, COMPLETING WORK BUT IS FINE OUTSIDE. PER THE PATIENT ACCORDING TO HER DOCTOR, HER EYES ARE HEALTHY AND SEEING PROPERLY. THIS REPORT REPRESENTS THE LENS IMPLANTED IN PATIENT'S RIGHT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LENS IMPLANTED IN PATIENT'S LEFT EYE.

  Patient problems: Discomfort; Visual Disturbances

  MAUDE report 5941108 ↗