TECNIS IOL ZCU525 (REF ZCU525U165)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 16.5D CYL5.25 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474664210), received between Dec 1, 2020 and Dec 1, 2020 — classified as 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
- Unintended Movement1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2020Unintended Movement; Unintended Movement
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD ROTATED APPROXIMATELY 11 DEGREES POST IMPLANT. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT¿S DAILY ACTIVITIES. IT WAS STATED THAT THE INITIAL OPERATIVE IOL AXIS ESTIMATE WAS FOR THE RIGHT EYE (OD) 087 DEGREES. HOWEVER, 3-MONTH POSTOPERATIVE IOL AXIS ESTIMATE OD WAS 076 DEGREES. THE UNCORRECTED VISUAL ACUITY OD AT THE 3-MONTH POSTOPERATIVE VISIT: 20/25. MANIFEST REFRACTION OD: +0.25 SPH. BEST-CORRECTED VISUAL ACUITY OD: 20/20. THERE WAS NO REPORTED VISUAL SYMPTOMS AT THIS VISIT. NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10926165 ↗
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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