TECNIS IOL ZCT225 (REF ZCT225U240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474552814), received between Feb 20, 2017 and Jan 14, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. How this data works · Data updated Oct 13, 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.

• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. IT WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL. THE SUSPECT IOL PIECES WERE DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 13261841 ↗
• MalfunctionApr 2, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN INSERTING AN INTRAOCULAR LENS (IOL) INTO THE EYE THE LENS WAS CRACKED, THEREFORE, THE LENS WAS REMOVED DURING THE SAME-DAY SURGERY. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE IS NOT AVAILABLE TO RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8472290 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT225, +24.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING MODERATE BLURRY VISION, UNEXPECTED POST OP REFRACTION AND PSEUDOPHAKIA. REPORTEDLY MODEL ZCT150, +25.5 DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS RECOVERING FROM THE EXCHANGE. THERE WAS NO INCISION ENLARGEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7509319 ↗
• InjuryNov 28, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT225 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT WAS DIAGNOSED WITH ANISOMETROPIA. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED AT EXPLANT. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 22.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING OKAY POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7065983 ↗
• InjuryFeb 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT CONTACTED ABBOTT MEDICAL OPTICS TO REPORT THAT HE HAD LENSES IMPLANTED (B)(6) 2016, IN HIS RIGHT EYE AND THEN HIS LEFT EYE. PATIENT REPORTS HE HAS NOT BEEN HAPPY WITH THE LENSES. HE REPORTS HIS VISION IS WORSE IN THE LEFT EYE BUT BAD ENOUGH IN THE RIGHT EYE TO BE A PROBLEM WHEN DRIVING AT NIGHT. HE INDICATED THAT HIS DOCTOR TOLD HIM HE HAS TO LIVE WITH IT, BUT PATIENT STATED HE IS NOT SATISFIED WITH THAT ANSWER. A CALL WAS MADE TO THE PATIENT WHO REPORTED HE IS SEEING STREAKS/SPIKES OF LIGHT MOSTLY IN THE LEFT EYE BUT ALSO A BIT ON THE RIGHT EYE. HEADLIGHTS ARE AN ISSUE. DRIVING AT NIGHT IS DIFFICULT; ONE HEADLIGHT APPEARS AS THREE. DAYTIME IS FINE. HAS SEEN HIS DOCTOR TWICE (IN (B)(6)) AND WAS TOLD HE HAS TO LIVE WITH IT AND SHOULD CONSIDER NOT DRIVING AT NIGHT. VISION WAS 20/15 IN THE RIGHT EYE FOLLOWING INITIAL SURGERY, BUT AFTER THE SECOND SURGERY THE VISION IS NOT NEARLY AS CLEAR. HE DOES NOT KNOW HIS CURRENT VISION BUT THE PRESCRIPTION ON HIS NEW GLASSES FOR THE RIGHT EYE IS SPHERE -.25, CYLINDER .50, AXIS 005; LEFT EYE SPHERE -.75, CYLINDER 1.50, AXIS 135. THE PATIENT HAS NOT RECEIVED HIS NEW GLASSES YET. IT WAS SUGGESTED TO THE PATIENT THAT HE MAY WANT TO SEEK A S

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6344432 ↗