TECNIS IOL ZCT225 (REF ZCT225U245)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC 1-PIECE 6.0MM 24.5D 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474552821), received between Dec 23, 2016 and May 21, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Product Quality Problem” (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 Problem2
- Product Quality Problem1
Patient problems
- No Code Available3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2020Product Quality Problem; Product Quality Problem
IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF ANTERIOR DEPOSITS ON LENS AND WAS REPLACED WITH THE SAME MODEL LENS WITH A DIFFERENT DIOPTER. THERE WAS NO INCISION ENLARGEMENT. ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER ACCOUNT REQUESTING ADDITIONAL INFORMATION HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 10079666 ↗InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS REPLACED IN A DIFFERENT PROCEDURE, THEREFORE EXPLANTED. REASON FOR EXPLANT WAS NOT PROVIDED. THE LENS WAS REPLACED WITH MODEL ZCU225 19.0 DIOPTER IOL. THERE WAS NO OTHER SURGICAL INTERVENTION SUCH AS INCISION ENLARGEMENT OR VITRECTOMY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 10014940 ↗InjuryDec 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD ZCT INTRAOCULAR LENS (IOL) EXPLANTED FROM HER RIGHT EYE AS SHE WAS INTOLERANT TO THE LENS WAS INTOLERANT. LENS WAS REPLACED WITH THE SAME MODEL, A SMALLER 23.0 DIOPTER LENS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6202706 ↗
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.
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