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TECNIS IOL ZCT600 (REF ZCT600U200)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.MM 20.0D CYL6.00 · 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 05050474604162), received between Jun 9, 2017 and Dec 18, 2017 — classified as 1 injury, 1 malfunction.

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

Device problems

  • Unintended Movement2

Patient problems

  • Blurred Vision1
  • No Code Available1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionDec 18, 2017Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) MALE PATIENT ON (B)(6) 2017. THE LENS ORIGINALLY PLACED AT 6 DEGREES, WAS MEASURED AT 170 DEGREES ON (B)(6) 2017. REPORTEDLY, THERE ARE NO PLANS FOR IOL REPOSITIONING. THE LENS REMAINS IMPLANTED IN THE EYE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7125030 ↗
  • InjuryJun 9, 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) YEAR-OLD MALE PATIENT. THE IOL, INITIALLY PLACED AT 179 DEGREES, WAS MEASURED AT ONE-WEEK POST-OPERATION VISIT AT 25 DEGREES. REPORTEDLY, THE PATIENT WAS COMPLAINING THAT THEIR VISION WAS NOT AS CLEAR AS THEY EXPECTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS REPOSITIONED AT 179 DEGREES ON (B)(6) 2017. (B)(6) 2017 - ONE DAY POST-REPOSITIONING: BCVA (BEST CORRECTED VISUAL ACUITY): 20/25, GRADE 1 CELLS, IOL POSITIONED AT 179 DEGREES. (B)(6) 2017: BCVA (BEST CORRECTED VISUAL ACUITY): 20/30, GRADE 1 CELLS, IOL POSITIONED AT 179 DEGREES AND FUNDUS EXAM CLEAR. NO FURTHER INFORMATION WAS RECEIVED.

    Patient problems: Blurred Vision; No Code Available

    MAUDE report 6632207 ↗

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Sources and updates

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