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TECNIS IOL ZCT400 (REF ZCT400U115)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 11.5D CYL4.00 · Class 3 · Implant

All models of TECNIS IOL (1344)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474553743), received between Dec 27, 2017 and Apr 10, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Unintended Movement1

Patient problems

  • Blurred Vision1
  • No Code Available1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZCT400 11.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. REPORTEDLY, THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO BLURRED VISION AND DYSPHOTOPSIA. THE INCISION WAS ENLARGED DURING THE REMOVAL OF THE LENS AND SUTURES WERE USED. A ZCT300 12.5 DIOPTER LENS WAS IMPLANTED AS A REPLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE BEST CORRECTED VISUAL ACUITY (BCVA) BEFORE THE LENS EXCHANGE WAS 20/30. THE ACCOUNT ALSO INDICATED THAT THE EXPLANTED LENS WAS DISCARDED AT THE SURGERY CENTER. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision; No Code Available

    MAUDE report 8498897 ↗
  • MalfunctionDec 27, 2017Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT THE SUBJECT HAD THE INTRAOCULAR LENS IMPLANTED ON (B)(6) 2017, AND A MISALIGNMENT OF 17 DEGREES, FROM 87 TO 70 DEGREES, WAS NOTED AT THE 1-MONTH VISIT FOR THE RIGHT EYE. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT IS STABLE AND DOESN'T WANT TO SEEK ANY TREATMENT AT THIS TIME. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: PATIENT HAD BILATERAL LENS IMPLANTS; THEREFORE, TWO REPORTS ARE BEING SUBMITTED, ONE FOR EACH IMPACTED EYE. THIS REPORT CAPTURES THE EVENT FOR THE RIGHT EYE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7150187 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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