TECNIS IOL ZLU375 (REF ZLU375U090)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 09.0D 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474690912), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Unstable1
Patient problems
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Unstable; Unstable
IT WAS REPORTED THAT DOCTOR HAS ISSUES WITH A TORIC LENSES THAT HAS ROTATED MULTIPLE TIMES IN A PATIENT. THE INITIAL INTRAOCULAR LENS (IOL) ROTATED AND WAS EXPLANTED. THEN IT WAS ALSO REPORTED THAT THE TORIC REPLACEMENT IOL WAS IMPLANTED AT 98 DEGREES, BUT THIS ONE ALSO ROTATED A FEW DAYS AFTER IT WAS IMPLANTED IN THE PATIENT'S LEFT EYE. DAY #1 POST OP, -1.00+2.00X130 20/25, LENS AT 91 DEGREES. DAY #8 POST OP, -2.00+4.25X110 20/25 LENS AT 53 DEGREES. THEN LENS ROTATED FROM 53 DEGREES TO 95 DEGREES. IT WAS NOTED THAT AT DAY # 1 POST OP LENS ROTATION -.50+1.00X74 20/20 LENS AT 95 DEGREES. THEN AT DAY # 8 POST OP ROTATION OF LENS -100+2.00X115 20/20 LENS AT 68 DEGREES. THERE WAS SECOND LENS ROTATION AND REPOSITIONED ON 12/10/2024 LENS ROTATED FROM 68 DEGREES TO 95 DEGREES, POST OP TOMORROW TO CHECK ON STABILITY. IOL REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE REPLACEMENT INTRAOCULAR LENS THAT WAS REPOSITIONED ROTATIONALLY. A SEPARATE REPORT IS BEING SUBMITTED FOR THE INITIAL IOL THAT ALSO ROTATED THEN EXPLANTED.
Patient problems: Discomfort
MAUDE report 20926067 ↗
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 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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