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TECNIS CL IOL Z9002 (REF Z900200150)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS CL MONO 13MM 15.0 · Class 3 · Implant

All models of TECNIS CL IOL (42)

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

Adverse event reports
5
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474530591), received between Aug 24, 2018 and Jan 27, 2021 — classified as 2 injuries, 3 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
  • Device Damaged Prior to Use1
  • Device Dislodged or Dislocated1
  • Separation Problem1

Patient problems

  • No Code Available2
  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1
  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionJan 27, 2021Break; Break

    IT WAS REPORTED THAT A MODEL Z9002 INTRAOCULAR LENS(IOL) HAD A BENT HAPTIC. THERE WAS PATIENT CONTACT. SUSPECT PRODUCT IS NOT BEING RETURNED AND WAS DISCARDED. NO FURTHER INFORMATION PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11240904 ↗
  • InjuryJun 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) DISLOCATED. THE LENS WAS LATER EXPLANTED AND REPLACED WITH A Z9002, SERIAL NUMBER (B)(4). THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED AND REPORTEDLY THE PATIENT HAS RECOVERED FROM THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 10151337 ↗
  • MalfunctionDec 5, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

    IT WAS REPORTED THAT A Z9002, 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS DAMAGED WHEN REMOVED FROM PACKAGING. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Patient Involvement

    MAUDE report 8132003 ↗
  • MalfunctionNov 16, 2018Separation Problem; Separation Problem

    IT WAS REPORTED THAT WHEN LENS WAS BEING INSERTED INTO THE EYE, IT WAS NOTICED THAT THE HAPTIC WAS TORN OFF. THERE WAS PATIENT CONTACT BUT NO HARM TO PATIENT. ANOTHER LENS, SAME MODEL AND DIOPTER WAS USED FOR THE REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8081893 ↗
  • InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A Z9002 15.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF AN UNEXPECTED POST-OPERATIVE REFRACTION. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 18.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 7812522 ↗

Other intraocular lens devices

All intraocular lens devices →

Sources and updates

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