TECNIS IOL ZCU150 (REF ZCU150U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474657816), received between May 8, 2020 and Sep 6, 2023 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2023Adverse 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 RIGHT EYE DUE TO PATIENT EXPERIENCING SIGNIFICANT HALOS, POOR CONTRAST, AND BLURRY VISION. ANOTHER JOHNSON & JOHNSON LENS OF SAME MODEL, BUT DIFFERENT DIOPTER (23.0 D) WAS USED AS A REPLACEMENT. NO UNPLANNED VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED AND NO PATIENT INJURY REPORTED. THE PATIENT IS DOING GREAT POST EXPLANT. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 17695896 ↗
• MalfunctionApr 17, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE ZCU150 INTRAOCULAR LENS HAD SCRATCH. THERE WAS A PATIENT CONTACT AND LEFT EYE WAS AFFECTED, HOWEVER THEY DOES NOT KNOW IF IT WAS INSERTED OR DOES NOT KNOW WHAT PART MADE CONTACT. THERE WAS NO USE ERROR. NO MEDICAL/SURGICAL INTERVENTIONS WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753357 ↗
• MalfunctionMar 20, 2022Break; Break

  IT WAS REPORTED THAT THE SURGEON STATED THAT AN INTRAOCULAR LENS (IOL) HAD IMPERFECTION ON IT AND HENCE HAD TO BE CUT OUT AND REMOVED FROM PATIENT'S LEFT EYE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831913 ↗
• MalfunctionJan 6, 2021Unstable; Unstable

  IT WAS REPORTED THAT A CLINICAL STUDY PATIENT HAD INTRAOCULAR LENS (IOL) ROTATION OF APPROXIMATELY 13 DEGREES. UNCORRECTED VISUAL ACUITY RIGHT EYE (OD) AT THE 3-MONTH POSTOPERATIVE VISIT: 20/25. MANIFEST REFRACTION OD: -0.25 SPHERE. BEST-CORRECTED VISUAL ACUITY OD: 20/16. SUBJECT REPORTED MILD HALOS AT THIS VISIT. NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME. THIS IS THE FINAL STUDY VISIT FOR THIS SUBJECT; COMPLETED THE STUDY ON (B)(6) 2020 IT WAS STATED THAT THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. OUTCOME DO NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. CURRENT PATIENT STATUS IS THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 11128625 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TECNIS INTRAOCULAR LENS (IOL) EXPLANTED FROM HIS LEFT (OS) OPERATIVE EYE DUE TO BLURRY VISION. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10446812 ↗
• InjuryAug 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SURGERY CENTER REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO MECHANICAL COMPLICATION OF INTRAOCULAR LENS. A REPLACEMENT LENS OF DIFFERENT MODEL/DIOPTER (ZCB00 23.5 D) WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10365854 ↗
• InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZCU150 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE DUE TO A MILDLY HYPEROPIC RESULT OF +.5 DIOPTER DUE TO USING THE UNOPTIMIZED ZCU A CONSTANT IN THE ORA (OCULAR RESPONSE ANALYZER). THE REPLACEMENT IOL IS ANOTHER MODEL ZCU LENS. THE PROCEDURE WAS UNEVENTFUL AND THE PATIENT IS OK. THE EXPLANTED LENS WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10037282 ↗