TECNIS IOL ZCT300 (REF ZCT300U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474553378), received between May 19, 2017 and Apr 24, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2020Break; Break

  THIS REPORT SUMMARIZES NOE> 1 <NOE MALFUNCTION EVENT. THE EVENT WAS RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURY REPORTED ASSOCIATED TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9998795 ↗
• InjuryMar 11, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT300 22.5 DIOPTER INTRAOCULAR LENS (IOL) LIKELY ROTATED GREATER THAN 10 DEGREES AND HAS CAUSING THE PATIENT TO EXPERIENCE BLURRY VISION. THE DOCTOR PLANS ON EXPLANTING THE IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9815674 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL ZCT300 22.5 DIOPTER WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) AS THE TORIC LENS DISLODGED AND DUE TO ANATOMICAL ISSUE. IT WAS INDICATED THAT THE LENS WAS IMPLANTED IN A 14 YEAR OLD MALE. THE ORIGINAL SURGERY WAS PERFORMED BY THE FIRST DOCTOR. BASED ON THE RECOMMENDATION OF THE ANESTHESIOLOGIST, THE PATIENT WAS REFERRED TO ANOTHER FACILITY FOR PATIENT'S SECOND EYE SURGERY IN ORDER TO RECEIVE GENERAL ANESTHESIA. UPON CONSULT WITH THE OTHER DOCTOR, IT WAS NOTED A PART OF THE LENS HAD MOVED INTO THE ANTERIOR CHAMBER. ACCORDING TO THE SURGEON THE PATIENTS TISSUE WAS TOO SOFT TO HAVE A TORIC POSTERIOR (PC) LENS REPLACED, BUT RATHER HAD TO HAVE A PC LENS SUTURED IN. THE REPLACEMENT LENS MODEL AND DIOPTER WAS NOT PROVIDED. THERE WAS NOTED THAT THERE WAS NO PATIENT INJURY AND THAT THE PATIENT IS DOING WELL. THE DEVICE IS NOT AVAILABLE FOR RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9353201 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SHE HAD PAIN IN THE EYE AFTER THE IMPLANTATION OF TECNIS TORIC INTRAOCULAR LENS AND TOOK EXTRA STRENGTH TYLENOL. PATIENT EXPERIENCED VISUAL DISTURBANCE IN HER LEFT EYE AND WHEN SHE CLOSED HER RIGHT EYE, (NON-OPERATIVE EYE) AND SHE ALSO OBSERVED WAVES IN THE LEFT EYE. PATIENT WENT TO A RETINA SPECIALIST WHO STATED THAT THERE WAS RETINAL SCARING FOR WHICH THE RETINA SPECIALIST HAS PLANNED FOR A RETINA SURGERY. REPORTEDLY, PAIN WAS BAD INITIALLY, HOWEVER, THE PATIENT IS FEELING BETTER NOW. SHE STILL HAS DISTORTIONS AND IS HOPING ONCE SHE GETS HER COMPANION EYE CATARACT SURGERY SHE EXPECTS TO BE FEELING BETTER. PATIENT IS ABLE TO DRIVE WITHOUT ANY ISSUES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Pain; Visual Disturbances

  MAUDE report 7477103 ↗
• InjuryMay 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE TO A AN UNEXPECTED OUTCOME, A TARGET MISS OF THE IMPLANT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THE LENS WAS REPLACED WITH A LOWER DIOPTER ZCT150 IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6579925 ↗