TECNIS IOL ZMB00 (REF ZMB00U0125)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 1- PIECE 6.0MM 12.5 US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474535473), received between Mar 31, 2017 and Feb 6, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
- Material Twisted/Bent1
Patient problems
- No Code Available2
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THE PATIENT EXPERIENCING EXCESSIVE GLARE. THE IOL WAS REPLACED WITH A NON JNJ LENS, MODEL INVISTA 12.5 DIOPTER. THERE WERE NO COMPLICATIONS SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Visual Disturbances
MAUDE report 21329621 ↗InjuryDec 28, 2018Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent
IT WAS REPORTED THAT A MODEL ZMB00 TECNIS MULTIFOCAL IOL (INTRAOCULAR LENS) DISLOCATED AND LENS HAPTIC WAS OBSERVED BENT OR KINKED AFTER IMPLANTING IN PATIENT'S EYE. THE LENS WAS EXPLANTED AND EXCHANGED FOR A MODEL ZMA00 12.0 DIOPTER IOL. PATIENT IS DOING WELL POST EXCHANGE. PRODUCT WILL NOT BE RETURN AS IT IS DISCARDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 8202034 ↗InjuryMar 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT PRESENTED WITH UNEXPECTED POST OP REFRACTION IN LEFT EYE AND EXPLANT WAS PERFORMED ON (B)(6) 2017. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE WHEN IT WAS EXPLANTED. THE PATIENT WAS REPORTED DOING FINE POST OP.
Patient problems: No Code Available
MAUDE report 6450205 ↗
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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