TECNIS CL IOL Z9002 (REF Z900200285)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS CL MONO 13MM 28.5 · Class 3 · Implant
All models of TECNIS CL IOL (42)
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 05050474530867), received between Feb 10, 2017 and Apr 8, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Torn 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
- Torn Material1
Patient problems
- Discomfort1
- 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.
InjuryApr 8, 2021Adverse 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 RIGHT EYE DUE TO THE PATIENT EXPERIENCING SYMPTOMATIC RESIDUAL HYPEROPIC ASTIGMATISM. DATE OF FIRST SYMPTOMS WAS ASKED, BUT UNAVAILABLE. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.
Patient problems: Discomfort; Visual Impairment
MAUDE report 11638971 ↗MalfunctionFeb 10, 2017Torn Material; Torn Material
INITIALLY IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) TORE ON THE INSERTER DURING HANDLING BUT PRIOR TO INSERTION. THE EVENT WAS NOT RELATED TO USER ERROR. THERE WAS NO PATIENT CONTACT. THROUGH FOLLOW UP IT WAS CLARIFIED THAT THE LENS TORE IN THE INSERTER, IT WAS NOT INSERTED AND IT WAS CONFIRMED THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Patient Involvement
MAUDE report 6324582 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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