TECNIS IOL ZCT300 (REF ZCT300U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553323), received between Sep 15, 2016 and Dec 30, 2020 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2020Adverse 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 PATIENT¿S RIGHT EYE DUE TO REFRACTIVE SURPRISE. IT WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL WITH A LOWER DIOPTER POWER (19.5). VITRECTOMY, INCISION ENLARGEMENT AND SUTURES WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected; Vitrectomy

  MAUDE report 11099424 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2018 DUE TO RESIDUAL REFRACTIVE ERROR. THE REPLACEMENT LENS WAS A MODEL ZA9003 IOL. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8251679 ↗
• InjuryApr 5, 2017Adverse 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 IN A SECONDARY SURGICAL PROCEDURE FROM THE LEFT EYE OF A (B)(6) FEMALE PATIENT BECAUSE OF COMPLICATIONS OF THE IOL, BLURRED VISION. REPORTEDLY, THE LENS WAS REPLACED WITH ANOTHER LENS, SAME MODEL SMALLER DIOPTER (+17.5). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6459634 ↗
• InjurySep 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) LENS WAS IMPLANTED BUT THE DOCTOR CHANGED DIOPTER AND THE LENS WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5954887 ↗