TECNIS IOL ZCT225 (REF ZCT225U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474552678), received between May 12, 2017 and Jun 30, 2021 — classified as 8 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT AFTER INSERTION OF THE INTRAOCULAR LENS (IOL), THE SURGEON ASKED FOR A VITRECTOR. PATIENT LEFT APHAKIC PER SURGEON. IT WAS LEARNED THAT THE (PRE-OP VISUAL ACUITY) W/CORRECTION = 20/80, PINHOLE 20/70-1. POSTOP (B)(6) 2021 W/O CORRECTION 20 @ 3 FEET, PINHOLE 2400. NO PATIENT INJURY. NO ADDITIONAL SURGICAL/MEDICAL INTERVENTION PERFORMED OR PLANNED. THE ISSUE HAS NOT SIGNIFICANTLY AFFECTED THE PATIENT'S ABILITY TO PERFORM ACTIVITIES OF DAILY LIFE. PATIENT IS DOING VERY GOOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12090062 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON HAD PLACED INTRAOCULAR LENS (IOL) INTO PATIENT'S LEFT EYE, HOWEVER, THE LENS WAS CUT OUT DURING THE SAME PROCEDURE DUE TO ANATOMY ISSUE THAT THE BAG FAILED AND THERE WAS NO SUPPORT. SURGEON BELIEVES THAT EVEN THOUGH THE PATIENT POSED NO APPARENT PRE-EXISTING CONDITION BEFORE SURGERY, PATIENT ANATOMY AND/OR PRE-EXISTING CONDITION MAY HAVE BOTH PLAYED A ROLE IN THE PATIENT'S BAG FAILURE. IN ADDITION, SURGEON ALSO BELIEVES THAT THE "STICKY NATURE" OF THE LENS MAY HAVE ALSO CONTRIBUTED TO THE POPPED CAPSULE. SO IT WAS ALSO POSSIBLE THAT THE PLACEMENT OF THE LENS CONTRIBUTED AS WELL. THERE WAS NO OTHER INJURY TO THE PATIENT. VITRECTOMY WAS PERFORMED AND THE PATIENT WAS LEFT APHAKIC. THE PATIENT WAS DISAPPOINTED BUT WELL POST-OPERATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 12082205 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 17.0 DIOPTER INTRAOCULAR LENS (IOL), WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO UNEXPECTED POST-OP REFRACTION. THE PATIENT'S VISUAL OUTCOME WAS NOT AS EXPECTED. THE IOL WAS EXCHANGED FOR ANOTHER ZCT225, BUT A LOWER DIOPTER, 15.0 LENS. THE SUSPECT PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED. IT IS INDICATED THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9840617 ↗
• InjuryJan 2, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT225 17.0 DIOPTER INTRAOCULAR LENS (IOL) ROTATED IN THE PATIENT¿S EYE. THE PHYSICIAN HAD TO REPOSITION THE LENS DUE TO THE ROTATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9539645 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SINCE HIS CATARACT SURGERY IN HIS RIGHT EYE IN (B)(6) OF 2017, HE HAS BEEN SEEING STARBURSTS AND ''CORONAS'' (SOMETIMES MULTICOLOR), ON HEAD LIGHTS AND STREET LIGHTS. THE LENS IMPLANTED WAS A ZCT225 17.0 THE PATIENT CLAIMED THAT HE SEES WELL FOR DISTANCE. THE PATIENT SAID THAT HE WAS TREATED WITH DROPS/ETC. FOR HIS DRY EYE AND IT MADE NO DIFFERENCE. HE STATED WHEN HE ATTENDS A HOCKEY GAME AND LOOKS OUT ON THE ICE HE SEES THE BRIGHT LIGHT OF THE ICE RINK AND THEN IT BLOCKS HIS ABILITY TO SEE THE LETTERS/ADS ON THE SIDE BOARDS. THE PATIENT STATED THAT HE TOLD HIS DOCTOR THAT HE DOES NOT WANT TO DO HIS 2ND EYE UNTIL THE ISSUE WITH THIS EYE IS RESOLVED. IT WAS LEARNT IN FOLLOW-UP THAT AFTER THE IMPLANT ABOUT 2 YEARS AGO, THE PATIENT¿S VISION IMPROVED TO 20/20 (?) BUT IN TIME, HE DEVELOPED A HAZE. HE TOLD HIS DOCTOR ABOUT IT AND HIS DOCTOR SAID THAT THE HAZE COULD BE FROM SCAR TISSUE THAT DEVELOPED FROM POST-OP, SO ABOUT 1 YEAR AFTER, THE PATIENT UNDERWENT LASER SURGERY. THE HAZE DISAPPEARED BUT THE ISSUES THAT HE MENTIONED INITIALLY SUCH AS STARBURSTS AND CORONAS (SOMETIMES MULTICOLOR), ON HEAD LIGHTS AND STREET LIGHTS STARTED TO APPEAR. HE WAS REFER

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8814788 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT''S OPERATIVE EYE AND REPLACED WITH ANOTHER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7061868 ↗
• InjuryAug 31, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT225 17.0 DIOPTER WAS EXPLANTED DUE TO AN INCORRECT LENS BEING PLACED INTO THE OPERATIVE EYE. THERE WAS NO MEDICAL INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6837075 ↗
• InjuryMay 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED. WHEN THE PATIENT CAME OUT OF THE OPERATING ROOM, THE SURGEON CHANGED HIS MIND ON WHAT IOL HE WANTED IMPLANTED AND TOOK THE PATIENT BACK TO THE OPERATING ROOM TO EXCHANGE THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available

  MAUDE report 6565215 ↗