TECNIS CL IOL Z9002 (REF Z900200130)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS CL MONO 13MM 13.0 · Class 3 · Implant
All models of TECNIS CL IOL (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474530553), received between Feb 2, 2021 and May 9, 2022 — classified as 1 injury, 2 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Capsular Bag Tear1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2022Break; Break
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD A BENT HAPTIC. THERE WAS PATIENT CONTACT, BUT NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14342731 ↗MalfunctionMar 29, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE LEADING HAPTIC OF AN INTRAOCULAR LENS (IOL) AMPUTATED UPON INSERTION. THE SURGEON REMOVED HAPTIC FRAGMENTS WITH SCISSOR AND FORCEPS, AND INSERTED A NEW LENS. PATIENT OUTCOME POST SURGERY IS REPORTED AS SATISFACTORY. THE LENS WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13935199 ↗InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A TECNIS INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED DURING THE INITIAL PROCEDURE BECAUSE THE LENS WENT THROUGH THE CAPSULE BAG. A REPLACEMENT LENS IS A NON-JOHNSON AND JOHNSON LENS. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Capsular Bag Tear
MAUDE report 11270080 ↗
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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