TECNIS IOL ZCT300 (REF ZCT300U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553293), received between Nov 21, 2016 and Sep 21, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT300 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO UNEXPECTED POST-OPERATIVE REFRACTION. THERE WAS NO INCISION ENLARGEMENT MADE AND THE PATIENT HAS RECOVERED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 20.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7900266 ↗
• InjuryOct 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SUDDENLY MOVED DURING THE IMPLANTATION OF A ZXT300 18.5 DIOPTER INTRAOCULAR LENS (IOL) IN THE RIGHT EYE (OD) ON (B)(6) 2017. THEREFORE, THE IOL WAS REMOVED AND REPLACED WITH A NON-AMO BACK UP LENS. THERE WAS NO INCISION ENLARGEMENT OR SUTURES USED, BUT A VITRECTOMY WAS PERFORMED. REPORTEDLY, THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 6933222 ↗
• MalfunctionFeb 2, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE OF A (B)(6) YEAR-OLD FEMALE PATIENT. AT ONE MONTH POST-OP VISIT, IT WAS NOTED A LENS MISALIGNMENT OF 42 DEGREES FROM THE ORIGINAL POSITION. REPORTEDLY THERE WAS NO PATIENT COMPLICATION OR INJURY AND THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6295408 ↗
• InjuryNov 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (+18.5 DIOPTER) WAS IMPLANTED ON (B)(6) 2016, INTO THE LEFT EYE OF A (B)(6) MALE PATIENT. THE SURGEON PLANNED TO EXPLANT THE LENS ON (B)(6) 2016, DUE TO THE INCORRECT DIOPTER SIZE AND UNEXPECTED VISUAL OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE LENS WAS EXCHANGED FOR ANOTHER AMO LENS, SAME MODEL, WITH THE CORRECT DIOPTRE SIZE FOR THE PATIENT (+21.0 DIOPTRE). NO PATIENT INJURY POST-OP WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6119148 ↗