TECNIS IOL ZCU450 (REF ZCU450U195)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 19.5D CYL4.50 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474663091), received between Dec 23, 2020 and May 5, 2023 — classified as 2 injuries.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Eye Injury1
- Inflammation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON(JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE. THE EXPLANTED IOL WAS CAUSING PIGMENT DISPERSION. EVENT WAS NOT DEBILITATING.REPORTEDLY, THERE WAS NO PATIENT INJURY. NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, CAPSULE TEAR, VITRECTOMY, OR SUTURES. THE IOL WAS REPLACED WITH A NON JNJ LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 16879344 ↗InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TOXIC ANTERIOR SEGMENT SYNDROME (TASS) OCCURRED IN THE LEFT EYE OF A PATIENT WHICH WAS IMPLANTED WITH AN INTRAOCULAR LENS. MOXIFLOXACIN OPHTHALMIC EYE DROPS WERE GIVEN AS A NORMAL PRE AND POST REGIMEN. THE PATIENT WAS ALSO TAKING DUREZOL EYE DROPS EVERY 1-2 HOURS. IN ADDITION, THE PATIENT WAS GIVEN A MEDROL DOSE PAK 4MG TABLETS PO (USE AS DIRECTED) ON (B)(6) 2020 POST SURGERY. IT WAS NOTED THAT THE PATIENT HAS RECOVERED. THE LENS REMAINS IN THE PATIENT'S EYE. THE ACCOUNT INDICATED THAT THEY HAVE BEEN DOING AN INVESTIGATION AND AT THIS POINT THEY DO NOT KNOW WHERE THE TASS IS COMING FROM. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR REPORT IS FOR THE INTRAOCULAR LENS, MODEL ZCU450. A SEPARATE EMDR WILL BE SUBMITTED FOR THE HEALON ENDOCOAT DEVICE.
Patient problems: Inflammation
MAUDE report 11062281 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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