TECNIS IOL ZCT400 (REF ZCT400U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553941), received between Oct 17, 2017 and Mar 30, 2023 — classified as 3 injuries, 1 malfunction.

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

• MalfunctionMar 30, 2023Unstable; Unstable

  IT WAS REPORTED THAT A PRODUCT COMPLAINT CONFIRMED IN AN UNMASKED CLINICAL STUDY HAD SOME CONCERNS ON AXIS POSITION OF LENS IN OS (LEFT EYE). 8° AT THE END OF SURGERY, 33° AT 1 DAY POSTOP, 13° AT 1 WEEK POSTOP, 18° AT 1 MONTH POSTOP, AND 23° AT 3 MONTHS POSTOP. THE SITE ALSO REPORTED THAT THERE WAS MODERATE CORNEAL EDEMA AT DAY 1 WHICH DID LIMIT THE VISUALIZATION OF THE TORIC AXIS MARKERS. IT WAS STATED THAT AT THE 1 MONTH POSTOPERATIVE VISIT, THE TORIC IOL WAS NOTED TO HAVE ROTATED BY 10°. TORIC IOL CONFIRMED TO HAVE ROTATED 10 DEGREES BETWEEN THE END OF SURGERY AND THE 1 MONTH POSTOPERATIVE VISIT. THE CUSTOMER CONFIRMED VIA EMAIL ON 02 FEB 2023 THAT THEY WERE MONITORING IT AND WOULDN¿T BE COMPLETING A SECONDARY SURGICAL INTERVENTION. IT WAS LEARNED THAT THE LENS REMAINS IMPLANTED. PATIENT NOT SYMPTOMATIC, NO ISSUES. NO NEXT ACTION PLANNED SO FAR. THESE WERE OBSERVED DURING POST-OP EXAMINATION. VISION PRE-OPERATIVE:20/40 LEFT EYE (OS); BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA); VISION POST-OPERATIVE:20/60 OS BCDVA. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16645698 ↗
• InjuryMar 20, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED ZCT400 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) (PER PATIENT IMPLANT CARD INFORMATION) ON (B)(6) 2019. THE ZCT400 LENS WAS EXPLANTED ON (B)(6) 2020 DUE TO ROTATION, AND IT WAS DETERMINED THAT A DIFFERENT DIOPTER WAS NEEDED FOR THE DESIRED RESULT. THE ZCT400 LENS REPLACED WITH ANOTHER ZCT400 BUT HIGHER DIOPTER (23.0)LENS. IT WAS REPORTED OUTCOME DOES NOT SIGNIFICANTLY INTER WITH ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. THERE IS NO FURTHER INFORMATION AVAILABLE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9858659 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT400, +21.5 DIOPTER) WAS EXPLANTED IN SECONDARY SURGERY BECAUSE OF THE PATIENT COMPLAINING OF DYSPHOTOPSIA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7115305 ↗
• InjuryOct 17, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT400 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017 AND ROTATED TO 150 DEGREES FROM THE TARGET DEGREE OF 115, WHICH WAS A DIFFERENCE OF 35 DEGREES. IN ADDITION, THE PATIENT'S POST-OPERATIVE VISUAL ACUITY WAS 20/70 AND HE COMPLAINED OF BLURRY VISION. THEREFORE, A SECOND SURGERY WAS PERFORMED ON (B)(6) 2017 TO ROTATE THE LENS BACK TO THE 115 DEGREE TARGET. POST-OPERATIVELY, THE LENS STAYED AT 115 DEGREES AND THE PATIENT'S VISUAL ACUITY WAS 20/25. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6956413 ↗