TECNIS IOL ZCT525 (REF ZCT525U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474603530), received between Jun 13, 2018 and Apr 11, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT525, +18.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING DOUBLE VISION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED AT EXPLANT. NO PATIENT INJURY REPORTED. THE REPLACEMENT LENS WAS A NON-TORIC, NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THE PATIENT WAS REPORTED TO BE FINE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8507390 ↗
• InjuryDec 13, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE ZCT525 +18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF A MECHANICAL COMPLICATION OF THE LENS AND THE PATIENT EXPERIENCING BLURRY VISION. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. A PCB00 LENS (DIOPTER UNKNOWN) WAS IMPLANTED AS A REPLACEMENT. FOLLOWING THE LENS EXCHANGE THE PATIENT WAS REPORTED DOING WELL. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8162997 ↗
• MalfunctionJun 13, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS (MODEL ZCT525 +18.0 DIOPTER) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2018. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATION AND/OR RELATED INJURY REPORTED. THE INTRAOCULAR LENS (IOL) ORIGINALLY PLACED AT 7 DEGREES, WAS MEASURED AT 25 DEGREES ONE WEEK POST-OP ON (B)(6) 2018. REPORTEDLY, NO ACTION HAS BEEN TAKEN AND THE LENS REMAINS IMPLANTED IN THE EYE. NO IOL REPOSITIONING IS PLANNED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERES WITH THE PATIENT''S DAILY ACTIVITIES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7595332 ↗