TECNIS IOL ZCT300 (REF ZCT300U145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553217), received between Mar 23, 2017 and Nov 13, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

• MalfunctionNov 13, 2018Unintended Movement; Unintended Movement

  IT WAS INITIALLY REPORTED THAT A ZCT300 14.5 DIOPTER INTRAOCULAR LENS (IOL) SEEMS TO ROTATE ON ITS OWN AND MUST BE ROTATED BACK TO ITS ORIGINAL POSITION IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THROUGH FOLLOW UP, THE CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING THE LENS ROTATED FROM 30° TO 35° COUNTERCLOCKWISE. THE LENS WAS NOT REPOSITIONED. THROUGH A LATER FOLLOW UP THE CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING VISUAL COMPLAINTS OF BLURRY AND FOGGY VISION THAT WERE FIRST NOTICED ON (B)(6) 2018. THE ZCT300 LENS WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A MODEL ZCT45 14.5 DIOPTER LENS. AT EXPLANT, THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S) AND NO VITRECTOMY REQUIRED. PATIENT OUTCOME POST EXCHANGE WAS REPORTED AS DAY 1 POST-OP GREAT WITH VISUAL ACUITY: 20/30. DAY 2 POST-OP GREAT VISUAL ACUITY: 20/30+. AT ONE-WEEK POST-OP VISUAL ACUITY WAS NOTED TO BE 20/70 AND THE REPLACEMENT LENS HAS ROTATED 10 DEGREES COUNTERCLOCKWISE, THE ACCOUNT IS NOT SURE IF THIS IS AN ISSUE DUE TO THE PATIENT¿S ANATOMY. THE PATIENT WILL BE EVALUATED AT THE ONE-MONTH POST-EXCHANGE EXAM TO DETERMINE IF FURTHER INTERVENTION IS REQUIRED. THE EVENT RELATED TO THE REPLACEM

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 8067018 ↗
• InjuryDec 18, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT300 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO UNEXPECTED POST-OPERATIVE REFRACTION. A NEW LENS WITH NEW MEASUREMENTS WAS IMPLANTED. THE LENS WAS REPLACED WITH A ZCT400 13.5 DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7126799 ↗
• MalfunctionMar 23, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INITIAL AXIS OF AN IMPLANTED ZCT300 INTRAOCULAR LENS (IOL) WAS 111 DEGREES. AT 1-MONTH THE AXIS WAS MEASURED AT 121 DEGREES. THEREFORE, THERE WAS A MISALIGNMENT OF 10 DEGREES. THE PATIENT HAD NO COMPLAINTS/COMPLICATIONS/INJURIES. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE IOL REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6429728 ↗