TECNIS CL IOL Z9002 (REF Z900200290)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS CL MONO 13MM 29.0 · Class 3 · Implant
All models of TECNIS CL IOL (42)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 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 05050474530874), received between Sep 25, 2019 and Jul 30, 2021 — classified as 1 injury, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
- Material Fragmentation1
Patient problems
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
- Vitrectomy1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT WHILE DOCTOR INSERTED AN INTRAOCULAR LENS(IOL) INTO THE PATIENT'S LEFT EYE BUT THE DOCTOR SAW THAT THE LENS HAD TORN AROUND ONE OF THE HAPTICS AND UPON FURTHER INVESTIGATION IT WAS NOTICED THAT THE MISSING HAPTIC REMAINED IN THE CARTRIDGE. ADDITIONAL DETAILS RECEIVED STATED THAT LENS WAS FULLY INSERTED AND REMOVED DURING THE SAME PROCEDURE. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTION SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. PROCEDURE WAS COMPLETED SUCCESSFULLY USING BACKUP LENS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12256384 ↗InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A Z9002 INTRAOCULAR LENS (IOL) WAS INSERTED BUT DOCTOR SAW THE CAPSULE BAG GOT DAMAGED. THE LENS WAS REMOVED. IT WAS NOTED THAT THERE WAS VITRECTOMY AND SUTURES WERE PLACED. THE DOCTOR PUT IN THE LENS AND THEN TOOK IT OUT. THERE WAS CAPSULE TEAR; BUT WAS UNCONFIRMED IF THAT WAS THE DOCTOR'S REASON FOR REMOVAL. THE SAME MODEL LENS WAS USED FOR THE REPLACEMENT. PATIENT WAS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Capsular Bag Tear; Vitrectomy
MAUDE report 9121151 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page