TECNIS IOL ZCT400 (REF ZCT400U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474553880), received between May 4, 2017 and Jul 13, 2018 — classified as 3 injuries, 2 malfunctions.

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 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.

• MalfunctionJul 13, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ZCT400 INTRAOCULAR LENS (IOL), IMPLANTED IN THE RIGHT EYE (OD), HAD ROTATED TO 120 DEGREES AT THE PATIENT'S SIX (6) MONTH POST OP VISIT. THE LENS WAS ORIGINALLY IMPLANTED AT 102 DEGREES. IT WAS NOTED THAT THE PATIENT HAD NO VISUAL DISTORTIONS; NOR DOES THE OUTCOME SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PRODUCT WILL NOT BE RETURNED AS THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7685590 ↗
• InjuryJun 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT400 18.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED BECAUSE THE PATIENT WANTED TO GO WITH A NON-TORIC LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7647861 ↗
• MalfunctionNov 1, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017 IN THE RIGHT EYE OF A (B)(6) FEMALE PATIENT. THE LENS ORIGINALLY PLACED AT 19 DEGREES, WAS MEASURED AT 07 DEGREES ON (B)(6) 2017. REPORTEDLY, NO REPOSITIONING OF THE LENS OR ANY FURTHER INTERVENTION WAS REQUIRED. THE LENS REMAINS IMPLANTED IN THE EYE AND THE PATIENT WAS REPORTED DOING WELL. BCVDA (BEST CORRECTED DISTANCE VISUAL ACUITY) WAS 20/25 (BOTH EYES) ON (B)(6) 2017. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6992575 ↗
• InjuryMay 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT AFTER IMPLANTATION OF ZCT400 18.5 DIOPTER INTRAOCULAR LENS (IOL) IN A MALE PATIENT'S LEFT EYE; THE PATIENT EXPERIENCED A 50° AXIS MISALIGNMENT IN THE LEFT EYE. HOWEVER, THROUGH FOLLOW UP IT WAS LEARNED THAT THIS INITIAL INFORMATION WAS INCORRECT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CLARIFIED/LEARNED THAT THE PATIENT COMPLAINED OF VISUAL DISTORTION. PATIENT'S UNCORRECTED VISUAL ACUITY AT 1- MONTH POSTOPERATIVE VISIT WAS 20/40 AND BEST CORRECTED VISUAL ACUITY WAS 20/20. PATIENT FEELS THAT THE LEFT EYE HAS A WEAKER VISION THAN THE RIGHT EYE. FURTHERMORE, IT WAS LEARNED THAT THE ZCT400 LENS WAS PLACED AT 004 DEGREES BASED ON OCULAR RESPONSE ANALYZER (ORA) ON (B)(6) 2016. ORA WAS INCORRECT AND LENS SHOULD HAVE BEEN PLACED AT 170 DEGREES PER AMO TORIC CALCULATOR. THE LENS WAS REPOSITIONED TO THE CORRECT PLACEMENT OF 172 DEGREES ON (B)(6) 2016. PATIENT'S VISION AT 1-DAY POST REPOSITIONING WAS 20/20. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6586602 ↗
• InjuryMay 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZCT400 18.5 DIOPTER, WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE FROM THE PATIENT''S RIGHT EYE. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. THE LENS WAS REPLACED WITH ANOTHER LENS MODEL ZCT225 HIGHER DIOPTER (19.5). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6546373 ↗