TECNIS IOL ZCT525 (REF ZCT525U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474603516), received between May 4, 2017 and Nov 24, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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 3 most recent of 3 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 (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 PATIENT¿

  Patient problems: Blurred Vision; Unspecified Infection; Visual Disturbances

  MAUDE report 10893215 ↗
• InjurySep 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED THAT THE WRONG POWER WAS INITIALLY IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE IOL WAS EXPLANTED AND REPLACED WITH MODEL ZCU450 17.5 DIOPTER POWER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10491255 ↗
• MalfunctionMay 4, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL), MODEL ZCT525, 17.0 HAD ROTATED BY 23 DEGREES POST IMPLANTATION. REPORTEDLY, THE POST-OP STATUS OF THE PATIENT WAS STABLE. THERE WERE NO INJURIES AND NO COMPLAINTS FROM THE PATIENT. TO DATE THE LENS REMAINS IMPLANTED AND THERE ARE NO PLANS TO REPOSITION THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6546413 ↗