Skip to content

TECNIS IOL PCB00 (REF PCB0000080)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS ITEC PRELOADED 1PC MONO 8.0D · Class 3 · Implant

All models of TECNIS IOL (1344)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474558021), received between Oct 29, 2017 and Jun 15, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Break1
  • Crack1
  • Defective Device1
  • Device Contamination with Chemical or Other Material1
  • Inaccurate Delivery1

Patient problems

  • No Patient Involvement2
  • No Clinical Signs, Symptoms or Conditions1
  • No Code Available1
  • No Information1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 15, 2021Break; Inaccurate Delivery; Break; Inaccurate Delivery

    IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS DAMAGED. IT WAS NOTED THAT IT WAS ALREADY DAMAGED WHEN IT WAS OPENED UP. THERE WAS PATIENT CONTACT WITH THE LENS. NO FURTHER INFORMATION WAS AVAILABLE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11996990 ↗
  • InjuryApr 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO ANISOMETROPIA. IOL WAS REPLACED WITH ANOTHER PCB00 LENS, BUT LOWER DIOPTER (11.5). THE PATIENT WAS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 9960832 ↗
  • MalfunctionSep 27, 2018Defective Device; Defective Device

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL PCB00) WAS DEFECTIVE. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Information

    MAUDE report 7913530 ↗
  • MalfunctionMay 16, 2018Crack; Crack

    IT WAS REPORTED THAT AFTER ADVANCING THE INTRAOCULAR LENS (IOL), THE NURSE HEARD A CRACKING SOUND. THE TIP OF THE CARTRIDGE WAS FOUND CRACKED. THE IOL WAS NOT USED OR COME INTO CONTACT WITH THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.

    Patient problems: No Patient Involvement

    MAUDE report 7517734 ↗
  • MalfunctionOct 29, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT THE NURSE AND THE SURGEON HAD PREPARED THE INTRAOCULAR LENS (IOL) AS PER THE DIRECTIONS FOR USE. THE SURGEON WAS ABOUT TO IMPLANT THE IOL INTO THE PATIENT¿S EYE BUT NOTICED A WHITE MARK ON THE LENS. HEALON WAS USED AS A VISCOELASTIC. THERE WAS NO PATIENT INVOLVEMENT/USER INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Patient problems: No Patient Involvement

    MAUDE report 6986228 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page