TECNIS IOL ZCT400 (REF ZCT400U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553927), received between Sep 29, 2016 and Aug 27, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (3 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 18, 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.

• InjuryAug 27, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT LEFT EYE DUE TO GLARE AND BLURRING. PATIENT ENDED UP SLIGHT MYOPIC AND OVER CORRECTED FOR ASTIGMATISM DESPITE INITIAL IOL CALCULATIONS USING J&J TORIC CALCULATOR AND IOL MASTER VALUES. SLIGHT ROTATION OF IOL WAS OBSERVED BY 8 DEGREES. REPEAT CALCULATIONS SHOW NEED FOR SLIGHTLY LESS POWER IN IOL AND TORIC COMPONENT. SYMPTOMS WERE NOTED TO SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES. THE IOL EXCHANGE WAS COMPLETED SUCCESSFULLY USING A MODEL ZCT225, 20.0 DIOPTER LENS AS REPLACEMENT. THERE WAS NO INJURY AND NO INTERVENTION WAS REQUIRED. THE PATIENT IS WELL SO FAR AND IMPROVED AFTER THE EXPLANT. VISUAL ACUITY PRE OPERATIVE : 20/30. VISUAL ACUITY POST OPERATIVE : 20/40. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10463670 ↗
• InjuryJul 22, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT SURGEON HAS A PATIENT WITH UNEXPECTED REFRACTIVE OUTCOME IN THE LEFT EYE, STATUS POST UNCOMPLICATED PHACO WITH A TORIC POSTERIOR CHAMBER INTRAOCULAR LENS PLACEMENT, AND SUBSEQUENT EXCHANGE WITH ANOTHER TORIC LENS. THE PATIENT HAD IRREGULAR ASTIGMATISM. INITIAL SURGERY WAS PERFORMED ON (B)(6) 2020 AND LENS WAS NOTED TO BE IN ALIGNMENT DURING IMMEDIATE POST-OPERATIVE COURSE. POST-OP DAY 30, THE PATIENT WAS FOUND TO HAVE TORIC MISALIGNMENT AND SURGEON¿S REPOSITIONING REVEALED THAT A HIGHER POWER TORIC WAS INDICATED. PATIENT AGREED TO LENS REPLACEMENT AND THE LENS EXCHANGE WAS PERFORMED WITHOUT COMPLICATION IN SECONDARY SURGICAL PROCEDURE ON (B)(6) 2020. RESULTANT UNCORRECTED VISION WAS POOR, AND REFRACTION REVEALS HIGH POST-OPERATIVE CYLINDER REQUIREMENT. NO CORNEAL OR MACULAR EDEMA OR EVIDENCE OF NEUROPATHY OR INFLAMMATION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT PATIENT WAS ALSO EXPERIENCING HALOS, BLURRY VISION, AND GLARE AFTER THE INITIAL SURGERY. THERE WAS ALSO AGE RELATED NUCLEAR CATARACT OBSERVED. THERE WAS TECNIS TORIC ROTATION OF MORE THAN 10 DEGREES. PATIENT WAS ALSO PRESCRIBED EYE DROPS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 10309372 ↗
• MalfunctionFeb 22, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT400 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS NOTICED ROTATED FROM ITS INITIAL 160 DEGREES PLACEMENT TO 4 DEGREES IN THE PATIENT'S LEFT EYE (OS) AT THE 6-MONTH VISIT WITH THE DOCTOR. THE LENS WAS IMPLANTED (B)(6) 2017. REPORTEDLY, THERE WAS NO PATIENT COMPLICATIONS OR RELATED INJURY AND THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE FOR THE PATIENT. THERE ARE NO PLANS AT THE MOMENT TO REPOSITION THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7291308 ↗
• MalfunctionSep 29, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A MODEL ZCT400 INTRAOCULAR LENS (IOL) DISLOCATED POST IMPLANT. THE EXACT DATE OF THE DISLOCATION IS UNKNOWN. THE LENS WAS EXPLANTED FROM THE MALE PATIENT'S EYE AND REPLACED WITH A DIFFERENT IOL. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. THERE WERE NO COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5989085 ↗