TECNIS IOL ZCT300 (REF ZCT300U095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553118), received between Mar 9, 2017 and Aug 8, 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.

• InjuryAug 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT''S RIGHT EYE DUE TO COMPLICATION OF REFRACTIVE SURPRISE. THE REPLACEMENT LENS IS THE SAME DIOPTER 9.5, BUT A DIFFERENT MODEL ZCT450. IT WAS INDICATED THE PRODUCT WILL NOT BE RETURNED. THE PATIENT OUTCOME IS UNKNOWN. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10382971 ↗
• InjuryFeb 7, 2020Unintended Movement; Unintended Movement

  A MALE PATIENT REPORTED THAT HE WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL), MODEL ZCT300 9.5 DIOPTER IN THE LEFT EYE (OS). POSTOPERATIVELY, ON (B)(6) 2019, THE LENS HAD TO BE REPOSITIONED DUE TO A 25-DEGREE ROTATION. NO OTHER SURGICAL INTERVENTIONS AND NO PATIENT INJURY WERE REPORTED WHEN THE LENS WAS REPOSITIONED. THE PATIENT REPORTS BLURRY VISION SOMETIMES WITH SIGNS AND TELEVISION, AND HE HAS GLARE ISSUE AT NIGHT TIME WHEN DRIVING. IT WAS NOTED THE SYMPTOMS ARE NOT DEBILITATING, AND HE IS ABLE TO PERFORM HIS DAILY TASKS/ACTIVITIES. THE PATIENT¿S MAIN CONCERN INVOLVED ISSUES WITH HIS RIGHT EYE, HOWEVER, THE PATIENT REPORTS FLOATERS IN THE LEFT EYE. REPORTEDLY, HIS DOCTOR INDICATED THE FLOATERS WERE CONGEALED VITREOUS MATERIAL THAT WERE FLOATING AROUND, THAT THE BRAIN WILL ADJUST TO IT WITH TIME. THE DOCTOR INFORMED THE PATIENT THAT THEY CAN DO A LASER SURGERY, BUT IT MAY NOT BE WORTH THE RISK. THE PATIENT NOTED THAT HE IS GETTING USED TO THE FLOATERS. THE PATIENT HAD A FOLLOW UP VISIT IN DECEMBER 2019 AND INDICATED THAT HIS DOCTOR DID NOT HAVE A SOLUTION FOR HIS GLARE. THE PATIENT ALSO REPORTS BAD ASTIGMATISM IN BOTH EYES (RIGHT EYE: 4.25 AND LEFT EYE:3.0). THE PATIENT WAS GIVE

  Patient problems: Blurred Vision; No Code Available; Vitreous Floaters

  MAUDE report 9684093 ↗
• MalfunctionMar 9, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) FEMALE PATIENT. THE IOL, INITIALLY PLACED AT 62 DEGREES, WAS MEASURED AT SIX-MONTH VISIT AT 80 DEGREES, WITH A DIFFERENCE OF 18 DEGREES. NO LENS REPOSITIONING WAS REQUIRED. REPORTEDLY, ON THE 6 MONTH QUESTIONNAIRE, THE PATIENT REPORTED DIFFICULTY KEEPING FOCUS WHILE READING ESPECIALLY AFTER READING FOR GREATER THAN 2 HOURS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 6392889 ↗