TECNIS IOL ZCU225 (REF ZCU225U140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 14.0D CYL2.25 · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474658851), received between Sep 18, 2020 and Nov 25, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Unintended Movement1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2020Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD POSSIBLE ROTATION OF 10 DEGREES. OPERATIVE IOL AXIS ESTIMATE: 082 DEGREES AND AT DAY-1 POSTOPERATIVE IOL AXIS ESTIMATE: 092 DEGREES. UNCORRECTED VISUAL ACUITY LEFT EYE (OS) AT THE DAY-1 POSTOPERATIVE VISIT: 20/63. SUBJECT REPORTED NO VISUAL SYMPTOMS AT THIS VISIT. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10902296 ↗InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED THAT THEY EXPLANTED AN INTRAOCULAR LENS (IOL). THE IOL WAS EXCHANGED FOR A NON-JOHNSON AND JOHNSON IOL. THE EXPLANTED IOL WAS INADVERTENTLY DISCARDED. WHEN ASKED FOR REASON FOR EXPLANT THE CUSTOMER EXPLAINED THAT THE PATIENT JUST WANTED A NON-JOHNSON AND JOHNSON LENS. IT WAS LEARNED THAT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. PATIENT OUTCOME WAS GOOD. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 10556579 ↗
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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