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TECNIS IOL ZCT300 (REF ZCT300U135)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 13.5D CYL3.00 · Class 3 · Implant

All models of TECNIS IOL (1344)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474553194), received between Oct 12, 2016 and Oct 12, 2016 — classified as 1 injury.

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

  • Unintended Movement1

Patient problems

  • No Code Available1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 12, 2016Unintended Movement; Unintended Movement

    A PHYSICIAN REPORTED A ZCT300 TORIC INTRAOCULAR LENS HAD ROTATED 25 TO 30 DEGREES POST IMPLANT IN THE RIGHT EYE OF A FEMALE PATIENT. AT DAY ONE POST-OP THE PATIENT¿S UNCORRECTED VISUAL ACUITY WAS 20/150 AND CORRECTED VISUAL ACUITY WAS 20/40. THE LENS WAS SUBSEQUENTLY REPOSITIONED IN A SECONDARY SURGERY. IN FOLLOW UP IT WAS LEARNED THE PATIENT IS DOING WELL.

    Patient problems: No Code Available; No Consequences Or Impact To Patient

    MAUDE report 6024777 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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