TECNIS IOL ZLU300 (REF ZLU300U195)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC LOW ADD 1-PC 19.5D 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474690530), received between Jan 16, 2021 and Jan 28, 2021 — classified as 2 injuries.
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
Patient problems
- Blurred Vision1
- Eye Pain1
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE EXPERIENCED VISUAL ISSUES SUCH AS BLURRY VISION, HALOS AND GLARE, PAIN, WAVY LINES AND COLOR ISSUES. THE PATIENT WAS DISSATISFIED AND IT WAS INDICATED THAT THE REPORTED SYMPTOMS EFFECTED PATIENT'S NORMAL DAILY ACTIVITIES SUCH AS DRIVING AND REPORTEDLY THE PATIENT WAS DEBILITATED. THE LENS WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND A COMPETITOR NON-JOHNSON AND JOHNSON LENS WAS USED AS A REPLACEMENT. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. IT WAS CONFIRMED THAT THE PATIENT IS DOING WELL AND NO INJURY WAS REPORTED. IT WAS NOTED THAT THE LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; Eye Pain; Halo; Visual Disturbances
MAUDE report 11248804 ↗InjuryJan 16, 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 IMPLANTED IN THE PATIENT¿S LEFT EYE. BUT THE PATIENT WAS UNHAPPY WITH THEIR POST-OP RESULTS. FOLLOW-UP CONFIRMS THAT VISION CONTINUES TO DECLINE DAILY AND THAT EXPLANT ALREADY OCCURRED. SUTURE WAS PLACED AND THERE WAS NO PATIENT POST-OP INJURY. PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Impairment
MAUDE report 11182534 ↗
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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