TECNIS IOL ZCT225 (REF ZCT225U135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474552609), received between Apr 26, 2018 and Nov 19, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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.

• InjuryNov 19, 2021Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT COMPLAINED ABOUT THEIR VISION AND THE DOCTOR FOUND PLASTIC PIECES BILATERALLY ON EACH INTRAOCULAR LENS (IOL). THE LENSES HAVE NOT BEEN EXPLANTED BUT THE DOCTOR DID ATTEMPT TO REMOVE THE FOREIGN BODY. A MICROORGANISM CULTURE FOUND NOTHING. THE DOCTOR SAW THE PATIENT IN (B)(6) 2021 WITH COMPLAINTS OF PHOTOPHOBIA, DECREASED VISION IN BOTH EYES WHICH IS THE FIRST RECORD OF ANTERIOR SEGMENT FOREIGN BODY. REPORTEDLY, THIS ISSUE WAS NOT NOTED IN POST OPERATIVE VISITS OR RETINA VISIT AT OUTSIDE OFFICES. INITIAL MEDICAL TREATMENT WITH AGGRESSIVE TOPICAL STEROIDS AND NSAIDS WAS SUCCESSFUL, INFLAMMATION AND VISION BOTH IMPROVED HOWEVER BOTH WORSENED AFTER TAPERING OF DROPS. THE PATIENT WENT THROUGH THE CYCLE A FEW TIMES WITHOUT SUCCESS OF TAPERING OFF DROPS. THROUGH THREE (3) WEEKS TAPERING DROPS, THE VISION REMAINED 20/40 BEST CORRECTED VISUAL ACUITY (BCVA). THE APPEARANCE OF FOREIGN BODY WAS COMPLETELY UNCHANGED AFTER SEVERAL MONTHS. THE DOCTOR DECIDED TO GO FOR SURGERY ON (B)(6) 2021 FOR FOREIGN BODY REMOVAL AND IT DID NOT BEHAVE AS EXPECTED. THE DOCTOR WAS UNABLE TO GET ENOUGH TO SEND FOR PATHOLOGY BUT THEY CULTURED A FRAGMENT AND THE AC WHICH WERE NEGATIVE

  Patient problems: Blurred Vision; Inflammation; Visual Disturbances

  MAUDE report 12844628 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED OF EXPERIENCING FLASHES OF LIGHT AND FLOATERS AFTER THE CATARACT SURGERY. AFTER A 10-DAY FOLLOW UP, SHE NOTICED THAT SHE CAN NOT SEE WELL OR DRIVE. THE PATIENT'S VISION IS STILL BLURRY AND DISTORTED. THE PATIENT HAS ISSUES WITH LOW LIGHT AND DURING CLOUDY DAYS OR AT NIGHT TIME, SHE CAN SEE THE SIGNS BUT IS NOT ABLE TO SEE THE WRITING ON THEM. THE COLORS ARE BRIGHTER/BOLDER, BUT EVEN DURING THE DAY THE PATIENT HAS LOTS OF GLARE. THE PATIENT USES OVER THE COUNTER READERS 1.5 WHICH ARE OK BUT EVEN WITH READERS SHE IS NOT HAPPY AND DOES NOT FEEL THE VISION IN EYES ARE BALANCED. THE PATIENT HAS NATURAL LENS IN HER LEFT EYE AS THERE IS NO CATARACT ISSUE WITH THAT EYE. THE PATIENT WOULD LIKE TO DRIVE AT NIGHT BUT SHE IS NOT ABLE TO DO SO AS A RESULT OF HER SYMPTOMS. THE PATIENT'S DOCTOR CAN NOT UNDERSTAND WHY THE PATIENT IS HAVING ISSUES AS THEY CHECKED THE CALCULATIONS WHICH ARE FINE AND EVEN WITHOUT CORRECTION THE PATIENT'S VISION IS 20/20 -2, PLANO -1, AXIS 115, WITH REFRACTION 20/15. THE TRIAL FRAME OR GLASSES DID NOT WORK FOR THE PATIENT ALTHOUGH THE RESULTS SHOWED NO SIGNIFICANT ISSUES. IT WAS INDICTED THAT THE PATIENT SEEMS TO BE VERY SENSITIVE. THE DOCTOR

  Patient problems: Blurred Vision; Visual Disturbances; Vitreous Floaters

  MAUDE report 11092214 ↗
• MalfunctionApr 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A MONOFOCAL TORIC INTRAOCULAR LENS (IOL) HAD CONCENTRIC RIDGES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 7466061 ↗