TECNIS IOL ZCT525 (REF ZCT525U120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474603417), received between Apr 2, 2017 and Nov 16, 2017 — classified as 2 injuries, 1 malfunction.

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

• InjuryNov 16, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT525 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, AT PATIENT'S 1 MONTH POST OP VISIT, THE LENS HAD ROTATED FROM ITS INITIAL PLACEMENT OF 100 DEGREES TO 85 DEGREES. THE PATIENT WAS SEEING 20/20 UNCORRECTED AND BEST CORRECTED. ADDITIONALLY, PATIENT REPORTED HALO'S AROUND LENS WHEN BRIGHT LIGHTS HIT IT. IN VERY BRIGHT LIGHT, SUCH AS STORES, MY EYES ARE "JUMPING" WHEN SCANNING AND MILD BLURRED VISION. REPORTEDLY, THERE WAS NO SIGNIFICANT INTERFERENCE WITH ACTIVITIES OF DAILY LIFE. THERE IS NO PLAN TO REPOSITION THE IOL AT THIS TIME. THERE WAS NO PATIENT INJURY OR COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 7038668 ↗
• MalfunctionOct 24, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCRATCH WAS NOTICED ON AN INTRAOCULAR LENS (IOL) AFTER IT WAS INSERTED INTO THE RIGHT EYE OF A FEMALE PATIENT. THE SURGEON COMMENTED THAT THE DEFECT WAS SMALL BUT VERY CENTRAL ON THE OPTIC; IT LOOKED LIKE A SMALL DIVOT ON THE POSTERIOR SURFACE OF THE IOL. REPORTEDLY, THE SURGEON REMOVED AND REPLACED THE LENS DURING THE SAME SURGICAL PROCEDURE WITHOUT ANY ISSUE. THERE WAS NO PATIENT INJURY AND NO INCISION ENLARGEMENT. THE PATIENT WAS REPORTED DOING WELL ONE DAY POST-OP AND VERY PLEASED WITH HER VISION. THE LENS WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6975431 ↗
• InjuryApr 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT525 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A UNEXPECTED REFRACTIVE OUTCOME. THE CUSTOMER NOTED THAT THERE WAS NO PRODUCT QUALITY ISSUE. THE LENS WAS REPLACED WITH A DIFFERENT MODEL LENS. THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 6452053 ↗