TECNIS IOL ZCU150 (REF ZCU150U155)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 15.5D CYL1.50 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474657700), received between Jun 4, 2022 and Jun 4, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Unstable” (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
- Unstable1
Patient problems
- Blurred Vision1
- Prolapse1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2022Unstable; Unstable
IT WAS INITIALLY REPORTED AN EXPLANT OF AN INTRAOCULAR LENS (IOL) WAS PLANNED DUE TO PATIENT COMPLAINTS OF BLURRY VISION FOR BOTH DISTANCE AND READING. THE IOL WAS SUBSEQUENTLY EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE RIGHT EYE AXIAL LENGTH WAS OFF CENTER. QUESTIONABLE PUSH ON LENS IMPLANT DUE TO ELEVATED INTRAOCULAR PRESSURE WAS INDICATED. ALSO, ASTIGMATISM WAS SHOWING +2.00 FOR THE RIGHT EYE (OD) AND ORA (OPTIWAVE REFRACTIVE ANALYSIS) WAS USED. THE PATIENT WAS OBSERVED DURING POST-OP EXAMINATION. THE BLURRY VISION WAS REPORTEDLY NOT CORRECTABLE BETTER THAN 20/60 WITH GLASSES. THE PATIENT HEALED WITH MORE ASTIGMATISM THAN PLANNED. PRE-OP VISUAL ACUITY 20/50, POST-OP VISUAL ACUITY 20/60. ADDITIONAL INFORMATION WAS PROVIDED STATING INITIALLY THE EXPLANT PROCEDURE WAS DELAYED AS THE PATIENT WAS OUT OF TOWN. HOWEVER, THE IOL WAS SUBSEQUENTLY EXPLANTED, BUT NO REPLACEMENT LENS WAS IMPLANTED AFTER THE EXPLANT WAS PERFORMED. THE PATIENT WAS LEFT APHAKIC AND WAS REFERRED TO A RETINAL SPECIALIST DUE TO NEEDING A 3-PIECE IOL SUTURED IN, DUE TO IRIS PROLAPSE AND POSTERIOR PRESSURE DURING EXPLANT. THE HEALTH CARE PROVIDER REPORTED NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTIONS
Patient problems: Blurred Vision; Prolapse; Visual Impairment
MAUDE report 14599156 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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