TECNIS IOL ZCT225 (REF ZCT225U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474552692), received between Aug 28, 2017 and Oct 28, 2020 — classified as 5 injuries.

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

• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE TECNIS TORIC INTRAOCULAR LENS (IOL) WAS FULLY INSERTED, WHEN THE SURGEON WAS ROTATING THE LENS INTO POSITION, IT CUT THROUGH THE PATIENT'S CAPSULAR BAG. A VITRECTOMY WAS REQUIRED AND THE IOL WAS REMOVED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, PATIENT HAS RECOVERED POST SURGERY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Capsular Bag Tear; Vitrectomy

  MAUDE report 10745263 ↗
• InjuryJul 31, 2019Failure to Eject; Failure to Eject

  IT WAS REPORTED ZCT225 18.0 DIOPTER INTRAOCULAR LENS (IOL) MODEL WAS STUCK IN THE CARTRIDGE AND IT WOULD NOT ADVANCE OR REMOVE. THERE WAS NO PATIENT CONTACT, THE PATIENT LEFT THE SURGERY CENTER WITHOUT HAVING A LENS INSERTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE), AND A SECOND SURGERY IS REQUIRED. IT WAS ALSO REPORTED OUTCOME SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8848948 ↗
• InjuryFeb 14, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT AN ZCT225 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO THE PATIENT HAVING A HYPEROPIC OUTCOME. THERE WAS NO INCISION ENLARGEMENT AND NO COMPLICATIONS REPORTED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 19.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8338276 ↗
• InjuryAug 17, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT225, +18.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE PATIENT WAS EXPERIENCING AN UNDESIRED REFRACTIVE ERROR. REPLACEMENT LENS WAS THE SAME MODEL, A LARGER DIOPTER OF +18.5. BEST CORRECTED VISUAL ACUITY: PRE-20/30 POST-20/20. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7795223 ↗
• InjuryAug 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A TECNIS TORIC INTRAOCULAR LENS (IOL), MODEL ZCT225 18.0 DIOPTER, WAS EXPLANTED ON (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6825991 ↗