TECNIS IOL ZCU300 (REF ZCU300U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474660052), received between Jan 7, 2021 and Feb 6, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Fold” (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 18, 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 6, 2021Failure to Fold; Use of Device Problem; Failure to Fold; Use of Device Problem

  IT WAS INDICATED THAT ALL SCRUB TECHS WERE OUT AND THE INTRAOCULAR LENS (IOL) MAY HAVE BEEN IMPROPERLY LOADED AS THE LEADING HAPTIC DID NOT FOLD PROPERLY. THE LENS WAS LOADED WITH THE FRONT HAPTIC SLIGHTLY STRAIGHT. AS THE LENS WAS INJECTED INTO THE PATIENT¿S RIGHT EYE, THE FRONT HAPTIC CAUGHT THE POSTERIOR CAPSULE AND CREATED A TEAR. THERE WAS PATIENT ZONULES ISSUE AND HAPTICS WOULD NOT SIT PROPERLY. THE LENS WAS IMPLANTED, THEN WAS CUT AND REMOVED FROM THE EYE DURING THE SAME PROCEDURE. IT WAS INDICATED THAT A VITRECTOMY WAS PERFORMED, THE SITE WAS SLIGHTLY ENLARGED TO ACCOMMODATE THE LENS AND SUTURES WERE USED TO CLOSE IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON AND JOHNSON 3-PIECE LENS. THE PATIENT WAS REPORTED TO BE FINE AND NO ISSUES WERE REPORTED UPON DISCHARGE. THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOTED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11290203 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS TORIC INTRAOCULAR LENS (IOL) HAPTICS WOULD NOT SIT PROPERLY UPON INSERTION BECAUSE THE PATIENT HAD ZONULES ISSUE. UNPLANNED VITRECTOMY ALONG WITH SUTURE WERE USED DURING THE PROCEDURE. THE REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. THE CUSTOMER ALSO INDICATED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135355 ↗