TECNIS IOL ZCT225 (REF ZCT225U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474552791), received between Jan 9, 2018 and Feb 16, 2018 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT225 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE (OD) DUE TO BLURRY VISION AFTER CATARACT SURGERY FOR DISTANCE AND NEAR WHICH AFFECTED PATIENT'S WATCHING TV, DRIVING AND READING. THE PATIENT''S BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/200 AND AFTER IOL EXCHANGE, THE MOST RECENT VISION WAS REPORTED TO BE 20/25. THE LENS WAS REPLACED WITH THE SAME MODEL OF A DIFFERENT DIOPTER (25.5) LENS. THERE WAS NO PATIENT CONTRIBUTING MEDICAL HISTORY REPORTED. THERE WAS NO INCISION ENLARGEMENT AND NO OTHER SECONDARY PROCEDURE WAS REQUIRED. IT WAS REPORTED THAT THE PATIENT IS DOING FINE AND NO PATIENT POST-OP INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Impairment

  MAUDE report 7278742 ↗
• InjuryJan 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT DEVELOPED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER HAVING AN IMPLANTATION OF A ZCT225 23.0 DIOPTER INTRAOCULAR LENS (IOL) ON (B)(6) 2017. REPORTEDLY, THE PATIENT APPEARS TO BE IMPROVING OR RESPONDING TO TREATMENT. FURTHER INFORMATION RECEIVED FROM THE DOCTOR (B)(6) 2018, STATES THAT THE PATIENT HAS NOT RECOVERED BUT HE DOESN''T BELIEVE THE LENS IS THE SUSPECT PRODUCT. HE BELIEVES IT WAS THE SLEEVES USED WHICH WAS THE ONLY VARIABLE BETWEEN THE PATIENTS HE SAW THAT DAY. THE DOCTOR DID NOT SPECIFY THE TYPE OF TREATMENT THE PATIENT WAS UNDERGOING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7177036 ↗