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TECNIS IOL ZCU300 (REF ZCU300U110)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 11.0D 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 05050474659971), received between Jul 23, 2020 and Jul 23, 2020 — classified as 1 injury.

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

Patient problems

  • Blurred Vision1
  • No Code Available1

Recent adverse event reports

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

  • InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A TECNIS TORIC II INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO BLURRY WITH RESIDUAL ASTIGMATISM. THE SYMPTOM WAS OBSERVED AT 1 DAY POST-OP EXAM. THE PATIENT'S PRE-OP VISUAL ACUITY WAS 20/40 AND REMAINS THE SAME POST SURGERY. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE SECONDARY PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision; No Code Available

    MAUDE report 10317563 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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