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TECNIS IOL ZCT300 (REF ZCT300U050)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 5.0D 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
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 05050474553026), received between Sep 30, 2016 and Aug 9, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Code Available1
  • No Patient Involvement1
  • Visual Impairment1

Recent adverse event reports

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

  • InjuryAug 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE WAS EXPLANTED THE PATIENT EXPERIENCING DECREASED VISUAL ACUITY AND RESIDUAL ASTIGMATISM POST CATARACT SURGERY. AT EXPLANT THERE WAS NO SUTURES, NO VITRECTOMY AND NO INCISION ENLARGEMENT REQUIRED. THE REPLACEMENT LENS WAS A DIFFERENT MODEL AND HIGHER DIOPTER. THE PATIENT IS REPORTED TO BE DOING FINE POST-EXCHANGE. VISUAL ACUITY PRE-OP (PRE-INITIAL IMPLANT): 20/40-2 (WITH GLASSES), VISUAL ACUITY POST-OP (POST-INITIAL IMPLANT):20/100-1, VISUAL ACUITY POST-OP (POST-REPLACEMENT):20/30-1. NO OTHER INFORMATION PROVIDED.

    Patient problems: No Code Available; Visual Impairment

    MAUDE report 8877344 ↗
  • MalfunctionSep 30, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT WHILE LOADING AN INTRAOCULAR LENS (IOL) INTO THE CARTRIDGE, A SMALL BLUE PARTICLE WAS NOTICED ON THE LENS, BELIEVED TO BE INSIDE THE OPTIC. THE SURGEON INSPECTED THE LENS AND TRIED TO SCRAPE THE PARTICLE OFF THE LENS AND ALSO THOUGHT THAT THE PARTICLE WAS INTEGRATED INTO THE OPTIC. THE IOL WAS NOT IMPLANTED AND THERE WAS NO PATIENT CONTACT. REPORTEDLY THE AMO SALES REPRESENTATIVE COLLECTED THE LENS TO BE INSPECTED BY THE MANUFACTURING SITE, AND THE PARTICLE HAD FALLEN OFF THE IOL AND REMAINED ON THE INSIDE OF THE PACKAGING. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 5992413 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

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Sources and updates

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