TECNIS IOL ZCT525 (REF ZCT525U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474603479), received between Oct 10, 2017 and Oct 14, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Positioning Problem” (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 2 most recent of 2 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 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 PATIENT HAD HER COMPANION EYE

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

  MAUDE report 9189124 ↗
• InjuryOct 10, 2017Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A ZCT525 15.0 DIOPTER INTRAOCULAR LENS (IOL) WOULD NOT CENTER PROPERLY. THE DOCTOR TRIED ROTATING THE IOL, BUT DECIDED TO EXPLANT THE LENS ON (B)(6) 2017. ANOTHER LENS, SAME MODEL AND DIOPTER DID NOT WORK, SO THE DOCTOR REPLACED THE LENS WITH A NON-AMO ANTERIOR CHAMBER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Code Available

  MAUDE report 6938984 ↗