TECNIS IOL ZCT225 (REF ZCT225U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474552715), received between Nov 30, 2016 and Mar 24, 2020 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2020. IT WAS LATER EXPLANTED ON (B)(6) 2020 DUE TO PATIENT INTOLERANCE OF THE NEW LENS. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE EXPLANT PROCESS. THE REPLACEMENT LENS IS A MODEL ZCU LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 9876050 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTRAOCULAR LENS WAS IMPLANTED IN PATIENT¿S LEFT EYE ON (B)(6) 2019 AND THE VISION IS UNCLEAR AND HAS ISSUES READING. FURTHER ANOTHER INTRAOCULAR LENS WAS IMPLANTED IN PATIENT¿S RIGHT EYE ON (B)(6) 2019 AND PATIENT CAN SEE PERFECTLY. REPORTEDLY PATIENT HAS SEEN DIFFERENT DOCTORS AT THE FACILITY AND HAS RECEIVED DIFFERENT OPINIONS. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT PATIENT IS EXPERIENCING BLURRY VISION AND THINKS THE ASTIGMATISM MAY NOT HAVE BEEN RESOLVED IN HER LEFT EYE AND MAY REQUIRE READERS. PATIENT CONFIRMED THAT SHE HAS NO ISSUES WITH HER RIGHT EYE AND CAN SEE CLEARLY. DOCTOR PRESCRIBED HER PREDNISOLONE EYE DROPS ON (B)(6) 2019 AND STATED THAT SHE MIGHT BE HAVING SOME MICROSCOPIC CORNEAL EDEMA. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Corneal Edema; No Code Available

  MAUDE report 8658726 ↗
• InjuryMar 22, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT225, 19.0 DIOPTER INTRAOCULAR LENS (IOL) HAD ROTATED, RESULTING IN INCREASED ASTIGMATISM. THE LENS WAS EXPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8446327 ↗
• InjuryMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO HALOS, BLURRY VISION, AND HEADACHES FROM STRAINING. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Headache

  MAUDE report 8393401 ↗
• InjuryAug 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZCT225 19.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE LENS DISLOCATED. THERE WAS AN INCISION ENLARGEMENT AND SUTURES WERE USED. A DIFFERENT LENS WAS IMPLANTED AS A REPLACEMENT (MODEL AND DIOPTER UNKNOWN). REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7750997 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT225, +19.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT¿S LEFT EYE. THE PATIENT WANTED NEAR VISION AND PATIENT¿S LENS CHOICE WAS TARGETED FOR MYOPIA. POST IMPLANT, THE PATIENT WAS NOT HAPPY WITH THE RESULTS. THE LENS WAS EXPLANTED AND EXCHANGED FOR A MODEL ZCT150, +16.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT REQUIRED AND NO PATIENT INJURY REPORTED. PATIENT WAS REPORTED TO BE DOING FINE AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7501660 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT225 +19.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING REFRACTIVE ERROR. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7463396 ↗
• InjurySep 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING IMPLANTATION OF A ZCT225 19.0 DIOPTER INTRAOCULAR LENS, A VITRECTOMY WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Vitrectomy

  MAUDE report 6841111 ↗
• InjuryMar 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 19.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6386203 ↗
• InjuryNov 30, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED/EXCHANGED IN A SECONDARY PROCEDURE DUE TO A REFRACTIVE MISS. THE REPLACEMENT LENS WAS THE SAME MODEL OF A HIGHER DIOPTER (21.5). THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6134149 ↗