TECNIS IOL ZCT225 (REF ZCT225U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474552760), received between Oct 3, 2016 and Aug 5, 2020 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO UNEXPECTED POSTOP REFRACTION. THERE WAS NO INCISION ENLARGEMENT REQUIRED AND OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10370037 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING ANISOMETROPIA. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND DIOPTER. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9248534 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. THE LENS WAS LATER EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS, DUE TO MECHANICAL COMPLICATION (OVER CORRECTED). AT EXPLANT THE INCISION WAS ENLARGED, BUT NO INJURY TO THE PATIENT. CUSTOMER ALSO INDICATED THAT THE LENS WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8360445 ↗
• InjuryMay 10, 2018Unintended Movement; Unintended Movement

  A REPORT WAS RECEIVED FROM A PATIENT STATING THAT HE HAD SURGERY YESTERDAY ON HIS RIGHT EYE ((B)(6) 2018) AND IS NOT HAPPY WITH OUTCOME. THE PATIENT SAYS HE CAN¿T SEE OUT OF HIS EYE AND IS NOT COMFORTABLE WITH HIS DOCTOR¿S INFORMATION THAT WAS GIVEN. IN FOLLOW-UP WITH THE PATIENT IT WAS LEARNT THAT ON THE DAY OF HIS SURGERY HIS VISION LOOKED CLOUDY AND THE DAY AFTER SURGERY HIS VISION WAS BLURRY. DURING THE FOLLOW-UP VISIT WITH HIS SURGEON, HE WAS INFORMED THAT THE LENS DISLOCATED. HE HAS ANOTHER FOLLOW UP VISIT SCHEDULED FOR (B)(6) 2018 TO HIS DOCTOR TO SEE IF THE LENS HAS RE-POSITIONED ITSELF. HE THEN HAS ANOTHER APPOINTMENT SCHEDULED ON (B)(6) 2018 TO REPOSITION THE LENS IF THE LENS REMAINS DISLOCATED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Impairment

  MAUDE report 7505609 ↗
• InjuryOct 12, 2016Unintended Movement; Unintended Movement

  A PHYSICIAN REPORTED A ZCT225 TORIC INTRAOCULAR LENS HAD ROTATED 12 DEGREES POST IMPLANT IN THE LEFT EYE OF A FEMALE PATIENT. THE LENS WAS SUBSEQUENTLY REPOSITIONED IN A SECONDARY SURGERY. THE PATIENT'S VISION IS MUCH BETTER SINCE ROTATION OF THE LENS. THE PATIENT'S UNCORRECTED VISUAL ACUITY POST ROTATION IS 20/20.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6024843 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN IMPLANTED A MODEL ZCT225 21.5 DIOPTER INTRAOCULAR LENS (IOL) ON (B)(6) 2016 INTO THE LEFT EYE OF A FEMALE PATIENT HOWEVER WAS NOT HAPPY WITH THE RESULT POST IMPLANT. THE PHYSICIAN EXPLANTED THE LENS AND REPLACED IT WITH A DIFFERENT MODEL IOL (ZCT400) OF THE SAME DIOPTER ON (B)(6) 2016. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THERE WAS NO POST-OP PATIENT INJURY. THE EXPLANTED LENS WAS NOTED AS DISCARDED.

  Patient problems: No Code Available

  MAUDE report 5995385 ↗