TECNIS IOL ZCU225 (REF ZCU225U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474658974), received between Mar 11, 2020 and May 14, 2026 — classified as 3 injuries, 1 malfunction.

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 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.

• MalfunctionMay 14, 2026Break; Manufacturing, Packaging or Shipping Problem

  THE FOLLOWING WAS REPORTED REGARDING THE JOHNSON (JNJ) INTRAOCULAR LENS (IOL). UPON OPENING THE PACKAGE, THE LENS WAS NOT SEATED AND WAS BENT. NO DETAILS WERE PROVIDED REGARDING THE IMPLANTATION OF THE LENS OR ANY IMPACT TO THE PATIENT OR USER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25168338 ↗
• InjuryJun 28, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AS THE PATIENT COMPLAINED OF BLURRY, DOUBLE VISION AND GLARE. PATIENT WAS NOT HAPPY WITH THEIR VISION ON DAY 1 POST OPERATION. THE SURGEON'S DIAGNOSIS WAS RESIDUAL ASTIGMATISM. THE FOLLOWING WAS PROVIDED UPON EXAMINATION: PATIENT'S VISION WAS 20/40 +1 UNCORRECTED, THE LENS WAS ON THE 2 DEGREE AXIS, AND THE REFRACTION WAS PLANO -1.25 AT 42 DEGREES TO 20/20 IN THE LEFT EYE. ANOTHER LENS OF DIFFERENT MODEL AND SLIGHTLY LOWER DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY REPORTED. NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT OUTCOME WAS GOOD. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 14848241 ↗
• InjuryDec 18, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S LEFT EYE WAS AN INCORRECT DIOPTER. THE LENS WAS EXPLANTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 11038888 ↗
• InjuryMar 11, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED ZCU225 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019; ORIGINAL ALIGNMENT WAS REPORTED AT 171. ON (B)(6) 2019 THE ZCU225 20.0 DIOPTER LENS WAS REPOSITIONED. THERE WAS NO INCISION ENLARGEMENT, NO INJURY, NO SUTURES, AND ACCOUNT BELIEVES A PHOTOREFRACTIVE KERATECTOMY (PRK) WAS DONE AFTER THE 2ND REPOSITION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9815120 ↗