TECNIS IOL ZCU150 (REF ZCU150U190)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 19.0D 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474657779), received between Jul 22, 2020 and Jul 7, 2022 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Blurred Vision1
- Eye Injury1
- No Consequences Or Impact To Patient1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED AN EXPLANT. ACCOUNT INDICATED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. THERE WAS NO REPORTED PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATION. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Eye Injury
MAUDE report 14951529 ↗InjuryAug 12, 2021Adverse 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/EXCHANGED FROM THE PATIENT'S RIGHT EYE DUE TO BLURRED VISUAL ACUITY OBSERVED DURING POST-OP EXAMINATION. THE EXPLANTED LENS WAS REPLACED WITH MODEL ZCU225 OF A HIGHER DIOPTER 18.5. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES WERE REQUIRED. PATIENT OUTCOME SANS CORRECTION (SC) 20/30, PRE-OP VISUAL ACUITY (VA) SC 20/40, POST-OP VA SC 20/50. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 12316965 ↗MalfunctionJul 22, 2020Break; Break
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10311658 ↗
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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