TECNIS IOL ZCT150 (REF ZCT150U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474552074), received between Oct 28, 2016 and Sep 23, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) CREATED AN ADDITIONAL CYLINDER, THEREFORE, THE LENS WAS EXPLANTED. THE INCISION WAS ENLARGED AND A 10-0 SUTURE WAS USED TO CLOSE THE WOUND. THERE WERE NO OTHER PATIENT CONSEQUENCES. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND HIGHER DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9107578 ↗
• InjuryJul 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCT150 16.5 DIOPTER LENS WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING DOUBLE VISION AND HYPEROPTIC SURPRISE. THE IOL WAS REPLACED WITH A SAME MODEL LENS BUT HIGHER DIOPTER (19.0). REPORTEDLY THE PATIENT IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8829594 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO UNINTENDED HYPEROPIA AND RESIDUAL ASTIGMATISM. THE EXPLANTED IOL WAS REPLACED WITH A ZCT 225 17.0 IOL. THERE WAS NO ADDITIONAL INTERVENTION RECEIVED. POST OP VISUAL ACUITY: 20/40. POST OP VISUAL ACUITY AFTER LENS REPLACEMENT: 20/20.

  Patient problems: No Code Available

  MAUDE report 8680612 ↗
• InjuryOct 28, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT150 16.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO THE LENS ROTATING 35 DEGREES, EVEN WITH A CTR (CAPSULAR TENSION RING). NO PATIENT POST-OP INJURY WAS REPORTED. THE LENS AND THE CTR WILL NOT BE RETURNED. THE LENS WAS EXPLANTED AND REPLACED WITH A ZCT150 14.0 (SMALLER) DIOPTER INTRAOCULAR LENS IN THE RIGHT EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6064328 ↗