TECNIS IOL ZLU375 (REF ZLU375U100)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 10.0D CYL3.75 · Class 3 · Implant
Data updated Oct 13, 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 05050474690936), received between Dec 13, 2024 and Dec 13, 2024 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unstable1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2024Unstable; Unstable
IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE AT 93 DEGREES. AT ONE DAY POST-OP, -1.00+1.50X120 20/25 AND LENS AXIS 89 DEGREES. ON DAY # 8 POST OP, -2.50 +3.50 X119 20/20, LENS AT 63 DEGREES, (SE) SPHERICAL EQUIVALENT -.75, DECIDE TO DO A LENS EXCHANGE TO ACHIEVE SE (SPHERICAL EQUIVALENT) OF ZERO. SUSPECT IOL WAS EXPLANTED ON (B)(6) 2024. THIS WAS REPLACED WITH THE SAME MODEL LENS 1.0D POWER SIZE LOWER THAN THE ORIGINAL IOL. THE REPLACEMENT IOL WAS IMPLANTED AT 98 DEGREES. SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO CAPSULAR TEAR, NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES AND NO DIFFERENT MEDICATIONS. WHEN THE LENS IS IN THE CORRECT POSITION, THE PATIENT DOES WELL AS SHE WAS. HOWEVER, A FEW DAYS LATER REPLACEMENT LENS ROTATED AGAIN. THIS REPORT IS FOR THE INITIAL INTRAOCULAR LENS THAT WAS EXPLANTED. A SEPARATE REPORT IS BEING SUBMITTED FOR THE REPLACEMENT IOL THAT ALSO ROTATED.
Patient problems: Visual Impairment
MAUDE report 20929594 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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