TECNIS CL IOL Z9002 (REF Z900200280)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS CL MONO 13MM 28.0 · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474530850), received between Mar 15, 2017 and May 5, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Break1
- Crack1
Patient problems
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A Z9002 28.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE AND REPLACED WITH A MODEL ZCT450 25.5 DIOPTER (IOL). NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6549279 ↗InjuryMar 15, 2017Bent; Break; Crack; Bent; Break; Crack
IT WAS REPORTED THAT AFTER INSERTION OF A Z9002 28.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE LEFT EYE OF A PATIENT, IT WAS OBSERVED THAT THE LENS APPEARED CRACKED BY THE HAPTICS (BOTH PIECES/SIDES). IN ADDITION IT WAS INDICATED THE HAPTIC WAS BENT/BROKEN. THE LENS WAS REMOVED, THE INCISION WAS ENLARGED, A 10.0 NYLON SUTURE WAS USED TO CLOSE THE WOUND. IT IS NOTED THAT THE PATIENT HAS RECOVERED.
Patient problems: No Code Available
MAUDE report 6405068 ↗
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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