TECNIS IOL ZCU225 (REF ZCU225U185)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 18.5D CYL2.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
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 05050474658943), received between Nov 17, 2020 and Apr 28, 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Discomfort1
- No Code Available1
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE ZCU225 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE). IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT DISSATISFACTION, WANTING MORE NEAR AND NOT A REFRACTIVE MISS, AND REPLACED WITH A ZKU225 18.5 DIOPTER IOL. IT WAS CONFIRMED THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE IOL EXPLANT/REMOVAL. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. ZCU225 IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS VISION AT POTENTIAL. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Discomfort
MAUDE report 16834854 ↗InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE BECAUSE PATIENT BECAME SLIGHTLY FARSIGHTED AND THERE WAS RESIDUAL MYOPIA NOTED POST-IMPLANTATION DAY ONE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Therapeutic Effects, Unexpected
MAUDE report 10854099 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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