TECNIS CL IOL Z9002 (REF Z900200115)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS CL MONO 13MM 11.5 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474530522), received between Jun 10, 2021 and May 6, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
- Material Split, Cut or Torn1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) SPLIT AS THE SURGEON WAS LETTING THE LENS OUT OF THE CARTRIDGE. THE LENS WAS NOT INSERTED AND ONLY THE CARTRIDGE TIP MADE CONTACT WITH PATIENT'S RIGHT EYE. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT IOL. THERE WAS NO OTHER PROBLEM AND THE PATIENT WAS FINE POST OPERATION. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14307306 ↗MalfunctionJun 10, 2021Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam
IT WAS REPORTED THAT THE DOCTOR ADVANCED A Z9002 INTRAOCULAR LENS (IOL), THE TOP HAPTIC WHICH WAS IN THE GROOVE DID NOT MOVE AND WAS SHEARED OFF WHILE TRYING TO IMPLANT. IT WAS INDICATED THAT THE LENS WAS OPENED BUT NOT IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11980006 ↗
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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