TECNIS IOL ZCU150 (REF ZCU150U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474657748), received between Jul 31, 2020 and Apr 29, 2026 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionApr 29, 2026Break; Use of Device Problem

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL). WHEN THE CUSTOMER TWISTED THE LOADER, INSTEAD OF THE LOADER ADVANCING THE LENS FORWARD IT RETRACTED THE LENS. THE HAPTIC WAS MANGLED. THE CUSTOMER BELIEVES THE CARTRIDGE CONTACTED THE PATIENT¿S LEFT EYE. HOWEVER, THEY ARE NOT SURE. REPORTEDLY, THE PATIENT WAS NOT INJURED. THERE WERE NO ADVERSE EVENTS, NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. A BACKUP IOL OF THE SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT OUTCOME WAS REPORTED AS ¿NO ISSUES, DOING WELL¿. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029901 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) INSERTED, AND THE DOCTOR STATED THAT THE LENS DID NOT LOOK RIGHT. THERE WAS PATIENT CONTACT WITH THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075731 ↗
• MalfunctionApr 12, 2021Unstable; Unstable

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED AT 139 DEGREES. THE EXPECTED IMPLANTATION WAS 139 DEGREES, HOWEVER, AT 1-DAY POST-OPERATIVE (OP), THE LENS ROTATED AT 115 DEGREES. THERE WAS NO PATIENT COMPLICATION OR INJURY. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT HAS RECOVERED. THERE IS NO SURGICAL INTERVENTION PLANNED. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11653839 ↗
• InjuryJul 31, 2020Adverse 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 A PATIENT'S RIGHT EYE (OD) DUE TO THE PATIENT BEING DISSATISFIED WITH HER VISION POST-OP. AFTER INITIAL IMPLANT, THE PATIENT NOTICED THAT COLORS APPEAR MORE VIVID, OBJECTS APPEAR BRIGHTER. THE PATIENT IS NOT HAPPY WITH HER OVERALL VISION, SHE FEELS HER NEAR VISION FIELD IS A LOT LARGER THAN IT WAS BEFORE THE SURGERY. IT WAS INDICATED THAT THE PATIENT IS HAVING TROUBLE SEEING IN THE DISTANCE, HAVING TROUBLE SEEING THE TELEVISION OR EVEN ACROSS THE STREET. HOWEVER, THE PATIENT DOES FEEL HER VISION IS IMPROVING. POSTOP REFRACTION, +2.25-.50X75. POST OPERATION DISTANCE VISION FOR OD: 20/60 -2, PH: 20/30 +1. AUTO REFRACTION TYPE: NON-DILATED AR; BINOCULAR PD: 57.0 (DIST): +1.75. MANIFEST REFRACTION: +1.50 ADD: +2.25, 20/20 J1+. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT IS FOR PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S LEFT EYE.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 10351426 ↗