TECNIS IOL ZLU300 (REF ZLU300U145)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 14.5D CYL3.00 · 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 05050474690431), received between Jun 10, 2024 and Jun 10, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE ZLU300 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT REPORTS COMPLAINTS OF BEING UNHAPPY WITH THE VISION QUALITY. IOL EXPLANT PROCEDURE WAS CANCELLED AND WILL BE RESCHEDULED. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE. 13-MAY-2024: ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF BLURRED VISON, NEGATIVE DYSPHOTOPSIA, DECREASED DEPTH PERCEPTION, BLUE TINTED VISION, AND TEMPORAL DISTORTION. THE EXPLANTED IOL WAS REPLACED WITH A ZCU225 15.5 DIOPTER IOL. THERE WAS NO PRODUCT QUALITY ISSUE THAT CONTRIBUTED TO THE IOL EXPLANT DECISION. THERE WAS NO COMPLICATION, INCISION ENLARGEMENT, SERIOUS INJURY, SUTURES, AND NO VITRECTOMY DURING THE EXPLANT PROCEDURE. PATIENT STATUS POST-LENS EXCHANGE WAS REPORTED AS VISUAL ACUITY (VA): 20/300, PINHOLE (PH): 20/100. PATIENT WILL CONTINUE ALL SURGICAL DROPS AND FOLLOW-UP IN 1-WEEK. ON (B)(6) 2024 VA WAS REPORTED AS 20/30+2. PATIENT WILL CONTINUE TO FOLLOW UP POSTOPERATIVELY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 19499099 ↗
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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