TECNIS IOL ZCT300 (REF ZCT300U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474553224), received between Jul 20, 2017 and Jan 30, 2020 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2020Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT. THE EVENT WAS RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURY REPORTED ASSOCIATED TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9648046 ↗
• MalfunctionJan 18, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ZCT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENTS RIGHT EYE AS THE REPLACEMENT LENS DURING AN IOL EXPLANT PROCEDURE. THERE WERE NO COMPLICATION AT THE TIME OF SURGERY BUT THE IOL WAS FOUND TO HAVE ROTATED 90 DEGREES (TO 180º INSTEAD OF 90º). A REPOSITIONING OF THE IOL HAS BEEN SCHEDULED. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT CAPTURES THE REPORTED EVENT WITH THE IOL REPORTED AS HAVING ROTATED. THE EXPLANTED LENS EVENT IS BEING REPORTED IN A SEPARATE MDR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9604685 ↗
• InjuryFeb 13, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT LENS MODEL, ZCT300 TORIC IOL (INTRAOCULAR LENS) ROTATED AND PATIENT WOULD LIKE TO HAVE BROADER RANGE OF VISION. FOR THOSE REASONS, LENS WAS EXPLANTED AND REPLACED WITH LENS MODEL, ZXT300. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8334308 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 15.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(46 2018, BECAUSE THE PATIENT EXPERIENCED VISUAL DISTURBANCES. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY AND THE PATIENT HAS RECOVERED. THE REPLACEMENT LENS WAS A ZCT450 13.0 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7695827 ↗
• InjuryApr 23, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT300 +15.0 DIOPTER) WAS IMPLANTED ON (B)(6) 2017. ONE-DAY POST OP PATIENT EXPERIENCED CORNEAL EDEMA. ONE-WEEK POST OP ON (B)(6) 2017 IT WAS NOTED THAT THE LENS WAS OFF AXIS AND HAD ROTATED COUNTER CLOCKWISE APPROXIMATELY 15-20 DEGREE CAUSING ASTIGMATISM AND PATIENT WAS EXPERIENCING POOR UNCORRECTED VISUAL ACUITY. SURGEON PERFORMED LENS REPOSITIONING ON (B)(6) 2018 WITHOUT ANY DIFFICULTY, REPORTEDLY NO SUTURES OR INCISION ENLARGEMENT WAS NEEDED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT PATIENT WAS DOING WELL, VISION HAS IMPROVED AND NO MORE INTERVENTION REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Corneal Edema; No Code Available; Visual Impairment

  MAUDE report 7453138 ↗
• InjuryDec 14, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED ROTATED AT THE SIX MONTH FOLLOW UP VISIT WITH THE DOCTOR ON (B)(6) 2017. THE LENS ROTATED FROM 108 DEGREES TO 135 DEGREES POST-OPERATIVELY, WHICH WAS A 27 DEGREE CHANGE. THE PATIENT COMPLAINED OF MODERATE BLURRED VISION AT ALL DISTANCES. REPORTEDLY, THE PATIENT COMPLAINT DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THERE WAS NO PATIENT COMPLICATIONS OR INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 7119992 ↗
• InjuryAug 31, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED A ZCT300 INTRAOCULAR LENS (IOL) (15.0 DIOPTER) WAS EXPLANTED AS INCORRECT POWER WAS SELECTED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER (16.5). IT WAS REPORTED THAT THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6836004 ↗
• InjuryAug 14, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED DUE TO REFRACTIVE SURPRISE WITH IOL ROTATION IN THE RIGHT EYE. THE DEGREE OF ROTATION WAS NOT PROVIDED. THERE WAS NO NEED FOR INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6793536 ↗
• InjuryJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED AND EXCHANGED DUE TO A POOR POST-OP REFRACTION. THROUGH FOLLOW-UP IT WAS CONFIRMED THAT THERE WAS NO PATIENT INJURY, NO PATIENT INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURE(S) WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6729808 ↗