TECNIS IOL ZCT225 (REF ZCT225U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474552722), received between Jan 25, 2017 and Feb 27, 2023 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2023Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  THE FOLLOWING ARTICLE WAS RECEIVED BASED ON LITERATURE REVIEW. ARTICLE: CLINICAL EVALUATION OF A SMALL APERTURE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS A NONRANDOMIZED INTERVENTIONAL CLINICAL TRIAL WAS DONE TO DETERMINE THE SAFETY AND EFFECTIVENESS OF THE IC-8¿ INTRAOCULAR LENS (IOL) IMPLANTED IN ONE EYE AND A MONOFOCAL OR MONOFOCAL TORIC IOL IMPLANTED IN THE FELLOW EYE IN ACCORDANCE WITH THE INDICATION (CATARACT AND PRESBYOPIA). THERE WERE INITIALLY 548 PATIENTS, 79 OF WHOM WERE CONSIDERED SCREEN FAILURES; LEAVING 469 SUBJECTS WHO WERE PROVISIONALLY ENROLLED WHEREIN 16 PATIENTS WERE DISCONTINUED FROM THE STUDY PRIOR TO SECOND EYE IMPLANTATION. A TOTAL OF 453 PARTICIPANTS WERE SUCCESSFULLY BILATERALLY IMPLANTED IN THE STUDY AND WERE DIVIDED INTO EXPERIMENTAL (CATARACT; N=343 PATIENTS) AND CONTROL (PRESBYOPIA; N=110 PATIENTS) GROUPS. THE EXPERIMENTAL GROUP (N=686 EYES) WERE IMPLANTED WITH A MONOFOCAL IOL (ACRYSOF® IQ SA60WF OR TECNIS® ASPHERIC MONOFOCAL ZCB00, JOHNSON & JOHNSON VISION), OR MONOFOCAL TORIC IOL (ACRYSOF® IQ SA6AT3, SA6AT4 OR TECNIS® ZCT150 OR ZCT225, JOHNSON & JOHNSON VISION) IN THE FIRST EYE AND THE IC-8¿ IOL (ACUSOFT, INC.) IN THE SECOND EYE. THE CONTROL GROUP (N=2

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16450321 ↗
• InjuryFeb 26, 2020Break; Break

  IT WAS REPORTED THAT A ZCT225 INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITH A BACK UP LENS OF THE SAME MODEL AND DIOPTER DURING THE INITIAL SURGERY BECAUSE THE LENS HAPTIC WAS BROKEN UPON INSERTION. REPORTEDLY, SUTURE(S) WERE REQUIRED. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9754056 ↗
• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS BEEN EXPERIENCING POOR VISION SINCE POST-OPERATIVE. FURTHERMORE, REFRACTIONS YIELDED A MYOPIC OUTCOME. AS A RESULT, ZCT225 TORIC IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM PATIENT'S EYE. PRODUCT IS EXPECTED TO RETURN. IT WAS ALSO NOTED THAT THERE WAS NO VITRECTOMY, NO INCISION ENLARGEMENT AND NO SUTURE REQUIRED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7868865 ↗
• InjuryDec 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT225 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED SUCCESSFULLY AND CENTERED WELL. HOWEVER, THE DOCTOR CHANGED THE PLAN FOR THE PATIENT'S REFRACTIVE OUTCOME AFTER PERFORMING INTRA-OPERATIVE MEASUREMENTS. THE MEASUREMENTS SHOWED THE PATIENT HAD MORE CYLINDER, WHICH REQUIRED A GREATER POWER. THEREFORE, THE LENS WAS EXPLANTED AND A HIGHER CYLINDER IOL WAS IMPLANTED. THERE WAS NO COMPLICATIONS DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7102717 ↗
• InjuryNov 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT WASN'T HAPPY AND REPLACED WITH A ZXT375 21.0 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7043362 ↗
• InjuryOct 18, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT225 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO MYOPIC OUTCOME. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 20.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6960343 ↗
• MalfunctionSep 28, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE TECHNICIAN NOTICED A SCRATCH ON THE INTRAOCULAR LENS (IOL) PRIOR TO LOADING. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6901492 ↗
• InjuryJun 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED THAT HAD NO MEASURED ASTIGMATISM IN IOL ON ITRACE ABERROMETRY. WHEN SEEING THIS UNHAPPY PATIENT POST OP, THE PHYSICIAN MEASURED FOR ASTIGMATISM WITH ITRACE, AND DISCOVERED THAT THE LENS IMPLANTED WAS NOT CORRECTING ANY ASTIGMATISM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6672218 ↗
• InjuryFeb 21, 2017Break; Break

  IT WAS REPORTED THAT A ZCT225 19.5 DIOPTER WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO A BROKEN HAPTIC. THROUGH FOLLOW UP IT WAS CONFIRMED THAT THE LENS WAS IMPLANTED ON (B)(6) 2017 AND THE PHYSICIAN WAS HOPING THAT THE LENS WOULD SETTLE IN THE EYE. HOWEVER DURING A POST-OP VISIT, THE PHYSICIAN NOTICED THAT THE HAPTIC WAS DAMAGED AND PROCEEDED TO EXPLANT THE LENS ON (B)(6) 2017. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 6347518 ↗
• MalfunctionJan 25, 2017Break; Break

  IT WAS REPORTED THAT DURING INSERTION INTO THE EYE THE HAPTIC BROKE OFF. THERE WAS PATIENT CONTACT AND REPORTEDLY AN ADVERSE EFFECT, INJURY OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6277153 ↗