TECNIS IOL ZCT300 (REF ZCT300U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474553347), received between Mar 14, 2017 and Sep 10, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO HAVING ANISOMETROPIA. THE REPLACEMENT LENS IS A ZCT300, HIGHER DIOPTER, SERIAL NUMBER (B)(4). NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. REPORTEDLY, PATIENT IS DOING FINE POST OPERATION.

  Patient problems: No Code Available

  MAUDE report 10518200 ↗
• MalfunctionSep 27, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ZCT300 TECNIS TORIC IOL (INTRAOCULAR LENS) WAS INITIALLY PLACED AT 6 DEGREES IN THE PATIENT'S RIGHT EYE (OD). AT 6-MONTH STUDY VISIT, THE LENS WAS FOUND TO BE AT 16 DEGREES. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE FOR THE PATIENT. THERE IS NO PLANNED OR PERFORMED INTERVENTION. THERE WAS NO PATIENT INJURY OR COMPLICATION. THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7917010 ↗
• MalfunctionMay 15, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE OF A (B)(6) MALE PATIENT. THE IOL, INITIALLY PLACED AT 112 DEGREES, AND ROTATED TO 136 DEGREES. REPORTEDLY, THE OUTCOME SIGNIFICANTLY INTERFERES WITH THE PATIENT''S ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6566154 ↗
• MalfunctionApr 25, 2017Unintended Movement; Unintended Movement

  THE INTRAOCULAR LENS (IOL) WAS PLACED AT 73 DEGREES IN THE LEFT EYE OF A MALE PATIENT ON (B)(6) 2017. THE LENS MEASURED AT 90 DEGREES POST-OPERATIVELY ON (B)(6) 2017 WITH A DIFFERENCE OF 17 DEGREES. THE PATIENT IS SATISFIED WITH HIS VISION AND NO REPOSITIONING IS SCHEDULED. THE LENS REMAINS IMPLANTED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO PATIENT COMPLICATION AND OR RELATED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6520918 ↗
• MalfunctionMar 14, 2017Unintended Movement; Unintended Movement

  AT THE POST-OPERATIVE FOLLOW UP VISIT, THE DOCTOR MEASURED THE INTRAOCULAR LENS (IOL) AXIS AT 10 DEGREES. THE IOL WAS POSITIONED AT 179 DEGREES DURING SURGERY. THE PATIENT HAD AN 11 DEGREE ROTATION/MISALIGNMENT NOTED AT THE 6 WEEK VISIT. NO FURTHER COMPLICATIONS OR ACTIONS WERE NOTED. NO REPOSITIONING IS REQUIRED, AS THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6404861 ↗