TECNIS IOL ZCT225 (REF ZCT225U140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474552616), received between Apr 25, 2018 and Oct 14, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR IMPLANTED, IN PATIENT'S LEFT EYE, A MODEL ZCT525 INTRAOCULAR LENS BASED ON THE RESULTS TAKEN FROM THE LENS CALCULATIONS DONE (B)(6) 2019. THE PATIENT HAD A 3D (DIOPTER) ASTIGMATISM CORRECTION REQUIREMENT. LENS WAS PLACED. REPORTEDLY, THE PATIENT HAD SOME CORNEAL EDEMA AND WAS 20/400 POST OP. DOCTOR INDICATED A LENS EXCHANGE MAY BE NECESSARY; HOWEVER, PATIENT DOES NOT WANT ANOTHER SURGERY DUE TO HER OTHER HEALTH CONDITIONS, REPORTED TO BE A RECENT STROKE. FURTHER INFORMATION WAS PROVIDED AND INDICATES THE DOCTOR USED THE RECOMMENDATION FROM THE TORIC CALCULATOR COMPLETED (B)(6) 2019. IT SUGGESTS A ZCT525 FOR CORRECTION OF 3 D OF CYLINDER SO THE ZCT525 WAS IMPLANTED. TO ASSIST THE DOCTOR, THE ACCOUNT EXECUTIVE RERAN THE NUMBERS THROUGH THE CALCULATOR AND IT RECOMMENDED A MODEL ZCT400. PATIENT WILL CONTINUE TO BE SEEN IN FOLLOW UP VISITS. PER THE DOCTOR, ON LINE J OF THE CALCULATOR IT RECOMMENDED A MODEL ZCT525 FOR IMPLANT IN THE PATIENT'S EYE; HOWEVER, AT POST OP, PATIENT WAS OVER CORRECTED FOR ASTIGMATISM. POST OP VISIT: (B)(6) 2019 - PATIENT VISUAL ACUITY 20/70 AND NO NEAR VISION. FURTHER UPDATE FROM THE DOCTOR RECEIVED (B)(6) 2019, REPORTS THE PATIE

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

  MAUDE report 9189135 ↗
• InjuryAug 6, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT225 INTRAOCULAR LENS (IOL) WAS GOING TO BE REPOSITIONED. THE DOCTOR THINKS THAT THE PATIENT PROBABLY ROTATED BETWEEN SURGERY AND DAY 1 POST OP. IT WAS NOTED THAT THE LENS WAS SITTING AT ABOUT 165 DEGREES BUT THE INTENDED AXIS WAS 135. LATER ON IT WAS LEARNT THAT THE REPOSITIONING PROCEDURE APPEARED TO WORK. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8863108 ↗
• InjuryApr 25, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZCT225 +14.0 DIOPTER) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 AND REPLACED WITH ANOTHER LENS, SAME MODEL HIGHER DIOPTER (+15.5 DIOPTER). THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY, BUT ONE SUTURE WAS USED. THE DOCTOR STATED THAT IT WAS HER ERROR IN PLACING THE WRONG LENS. THE PATIENT RECOVERED WITH NO FURTHER ISSUES. ALSO, THAT THE CALCULATION WAS INCORRECT, WHICH LEFT THE PATIENT WITH RESIDUAL ASTIGMATISM AND BEING FARSIGHTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7463471 ↗