TECNIS IOL ZLB00 (REF ZLB00U0105)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PC 6.0MM 10.5D LOW ADD US · 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 05050474560482), received between May 3, 2017 and May 3, 2017 — 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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2017Appropriate Device Problem Term/Code Not Available
A REPORT WAS RECEIVED THAT A TECNIS 1 MULTIFOCAL (TMF) MODEL ZLB00 10.5 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT¿S RIGHT EYE AS THE POST-OPERATIVE REFRACTIVE MEASUREMENT WAS +1.75. THE LENS WAS REPLACED WITH ANOTHER ZLB00 IOL OF A HIGHER DIOPTER (12.5). THE SURGEON¿S COMMENTS WERE THE EXPLANT PROCEDURE WAS UNCOMPLICATED WITH NO CHANGE IN WOUND STRUCTURE. THE SURGEON EXPLAINED THE IOL MASTER AND ORA (OCULAR RESPONSE ANALYZER) DID NOT MATCH AND THE SURGEON CHOSE TO USE THE ORA DATA TO SELECT THE LENS. THE PATIENT OUTCOME IS OF SATISFACTORY CONDITION.
Patient problems: No Code Available
MAUDE report 6541987 ↗
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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