TECNIS IOL ZCT525 (REF ZCT525U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474603509), received between Oct 7, 2016 and Nov 24, 2020 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2020Unintended Movement; Unintended Movement

  A FEMALE PATIENT REPORTED ISSUE WITH HER IMPLANTS. SHE INDICATED THAT A TOPOGRAPHY WAS NOT USED BY HER DOCTOR WHEN SHE HAD LENS IMPLANTS AND THAT THEY BOTH ROTATED OFF THE CORRECT AXIS. THE PATIENT HAD MACULAR PUCKER AND A VITRECTOMY IN THE (B)(6) 2018 WHICH AS THE PATIENT PUT IT, IT MAY HAVE BEEN CAUSED BY WEAK ZONULES. WHEN THE LEFT EYE WAS IMPLANTED ON (B)(6) 2019, THE PATIENT NOTICED A DIAGONAL LINE IN HER VISION AND WHEN INFORMED HER DOCTOR, SHE WAS TOLD THAT THE LENS HAD ROTATED OFF ITS AXIS. THE LEFT EYE¿S LENS ROTATION AND REPOSITIONING OCCURRED ABOUT 2 WEEKS FROM THE DATE IT WAS IMPLANTED. PATIENT INDICATED THAT WHEN THE LENS WAS ROTATED BACK, IT CAUSED A WRINKLE IN THE CAPSULE ON (B)(6) 2019. THE RIGHT EYE THAT WAS IMPLANTED ON (B)(6) 2019 ALSO ROTATED, BUT NO REPOSITIONING WAS DONE ON THIS EYE. NO INFORMATION ABOUT THE DEGREE OF ROTATION WAS PROVIDED TO THE PATIENT. THE PATIENT EXPERIENCED HEMORRHAGING AND AN INFECTION AND WAS TOLD THAT THEY CAUSED SCAR TISSUES. THE PATIENT HAD YTTRIUM-ALUMINUM GARNET (YAG) POSTERIOR CAPSULOTOMY LASER PROCEDURE DONE ON BOTH EYES IN (B)(6) 2020 DUE TO OPACITY IN THE RIGHT EYE AND TO HELP WITH THE WRINKLED CAPSULE IN THE LEFT EYE. THE PATI

  Patient problems: Blurred Vision; Unspecified Infection; Visual Disturbances

  MAUDE report 10893246 ↗
• InjuryOct 7, 2016Adverse 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 PATIENT'S LEFT EYE DUE TO VISUAL ISSUES WHERE THE VISUAL ACUITY WAS 20/70 POST-OP WITH GLARE 20/400 AND -1.0 + 1.75 X 160. PRIOR TO THE INITIAL IMPLANT, IT WAS -3.75 + 3.00 X 101. LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED AND NO PATIENT INJURY WAS REPORTED. THE LENS WAS REPLACED IN A SECONDARY SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 6012883 ↗