TECNIS IOL ZCU375 (REF ZCU375U205)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 20.5D CYL3.75 · 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 05050474700574), received between Nov 5, 2020 and Nov 5, 2020 — classified as 1 injury.
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 Problem1
Patient problems
- No Code Available1
- Vitrectomy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 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 REMOVED AND REPLACED FROM A STUDY PATIENT DUE TO LOOSE ZONULES AND VITREOUS IN THE ANTERIOR CHAMBER. IT WAS LEARNED THAT THE EVENT WAS NOT IOL RELATED. NEVERTHELESS, THERE WAS VITRECTOMY AND INCISION ENLARGEMENT. POST-OP DAY 1 THE PATIENT HAD SCATTERED HYPHEMA AND SIGNIFICANT CORNEAL EDEMA. UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) AT DAY 1 WAS HAND MOTION (HM). AT FOLLOW-UP EXAM, HYPHEMA WAS STILL PRESENT, AND CORNEAL EDEMA BUT HAD IMPROVED HOWEVER, UCDVA WAS STILL AT HM. INTRAOCULAR PRESSURE (IOP) WAS ELEVATED TO 34MMHG DUE TO HYPHEMA. STARTED SUBJECT ON OCULAR HYPOTENSIVE MEDICATIONS. VISUAL ACUITY (VA) WAS STILL HM AND HYPHEMA AND ELEVATED IOP WERE NO IMPROVEMENT. HENCE, THE SUBJECT WAS REFERRED TO A GLAUCOMA SPECIALIST. THE LENS WAS REPORTED TO BE DISCARDED ON SITE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available; Vitrectomy
MAUDE report 10797037 ↗
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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