TECNIS IOL ZCU600 (REF ZCU600U140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 14.0D CYL6.00 · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474665347), received between Dec 14, 2023 and Dec 14, 2023 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Capsular Bag Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AFTER FULLY INSERTING THE ZCU600 MODEL INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) AN UNPLANNED VITRECTOMY WAS REQUIRED WITH SUTURES PLACED AFTERWARDS. THERE WAS NO PRODUCT QUALITY ISSUE WITH THE IOL HOWEVER, PATIENT WITH POSTERIOR CAPSULAR TEAR CONTRIBUTED TO THE VITRECTOMY. THERE WAS NO INCISION ENLARGEMENT AND THE SAME PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON SURGICAL VISION LENS, DIOPTER SIZE UNKNOWN. PATIENT STATUS POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Capsular Bag Tear
MAUDE report 18332479 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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