TECNIS IOL ZCT225 (REF ZCT225U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474552777), received between Sep 29, 2017 and Apr 29, 2021 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE); PRE-OPERATIVE VISION WAS REPORTED AS 20/50. IOL WAS EXPLANTED DUE TO COMPLAINTS OF RESIDUAL MYOPIA AND ANISOMETROPIA. IT IS UNKNOWN IF THE INCISION WAS ENLARGED. THERE WAS NO SUTURE(S), NO VITRECTOMY, AND NO PROCEDURE DELAY. NO MEDICAL ATTENTION WAS SOUGHT AND NO MEDICATION WAS PRESCRIBED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING EXPLANTED IOL WAS REPLACED WITH SAME MODEL LENS WITH A DIFFERENT DIOPTER SIZE. AND THAT THE PATIENT OUTCOME POST LENS EXCHANGE WAS REPORTED AS 20/40, 1-DAY POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 11750551 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 INTRAOCULAR LENS (IOL) 22.0 DIOPTER WAS EXPLANTED DUE TO POWER CHANGE. IT WAS REPLACED WITH A ZCT400, 21.0 DIOPTER POWER. IT WAS NOTED THAT THERE WAS NO INCISION ENLARGEMENT. THERE WAS NO PATIENT INJURY, PATIENT DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8925900 ↗
• MalfunctionJul 31, 2019Crack; Crack

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO CARTRIDGE TIP CRACKED OR DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844471 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO UNEXPECTED POST-OP REFRACTION. THE EXPLANTED LENS WAS REPLACED WITH A DIFFERENT MODEL AND DIOPTER LENS. THE PATIENT HAS RECOVERED AND THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8534494 ↗
• InjuryApr 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED A BILATERAL INTRAOCULAR LENS (IOL) IMPLANT. THE FIRST LENS WAS IMPLANTED IN HER RIGHT EYE (OD) ON (B)(6) 2018 AND THE SECOND LENS WAS IMPLANTED IN HER LEFT EYE (OS) ON (B)(6) 2018. THE PATIENT INFORMED HER SURGEON, DURING ROUTINE FOLLOW UP VISITS, THAT IMMEDIATELY AFTER SURGERY SHE STARTED EXPERIENCING SOME VISUAL ISSUES. ON HER LAST VISIT TO THE SURGEON IN (B)(6) 2019, A 2ND YAG PROCEDURE WAS PERFORMED, ONE IN EACH EYE TO TRY TO IMPROVE THINGS. ALSO EYE DROP MEDICATIONS WERE PRESCRIBED FOR HER EYES. DESPITE HER VISUAL ACUITY IS AT 20/20, SHE CONTINUES TO SEE A FILM MOVING OVER HER EYES WHEN IN NATURAL DAYLIGHT AND GLARE WITH ANY LIGHT SOURCE; ESPECIALLY, ARTIFICIAL LIGHT. SHE ALSO MENTIONED THAT HER PERIPHERAL VISION SEEMS TO BE DIMINISHED AND SHE FEELS LIKE SHE CAN ACTUALLY SEE THE EDGES OF THE LENS LIKE A LINE IN HER VISION. THE PATIENT COMMENTED THAT THE SYMPTOMS INTERFERE WITH HER NORMAL ACTIVITIES INCLUDING NIGHT DRIVING. HER SURGEON DOES NOT UNDERSTAND WHY SHE HAS THESE SYMPTOMS, BUT THERE IS NO PLAN FOR A FUTURE TREATMENT SUCH AS LENS EXCHANGE OR PRESCRIPTION GLASSES. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE LEFT EYE. A SEPA

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8508511 ↗
• InjuryNov 9, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZCT225 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE LENS WAS COMING OUT OF THE CAPSULAR BAG, POSSIBLY DUE TO THE PATIENT RUBBING THE OPERATIVE EYE. THE REPLACEMENT LENS WAS A NON-AMO LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7012475 ↗
• InjuryOct 30, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT225 22.0 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 THE POWER OF THE LENS NEEDED TO BE CORRECTED (UNEXPECTED POST-OPERATIVE REFRACTION). THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 25.0. REPORTEDLY, THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6989295 ↗
• MalfunctionSep 29, 2017Scratched Material; Scratched Material

  AFTER THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, THE DOCTOR NOTICED A SCRATCH ON THE LENS. THEREFORE, THE DOCTOR REMOVED IT AND REPLACED IT WITH THE BACKUP IOL OF THE SAME MODEL AND DIOPTER. THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6906329 ↗