TECNIS IOL ZMA00 (REF ZMA00U0240)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 3- PIECE 6.0MM 24.0 US · Class 3 · Implant
- 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 05050474536883), received between Mar 29, 2020 and Mar 29, 2020 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Code Available1
- Visual Disturbances1
- Vitrectomy1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZMA00 +24.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING MECHANICAL FAILURE. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE MECHANICAL FAILURE SYMPTOMS REPORTED WERE DISTORTED VISION AT DISTANCE AND NEAR WITH A CONSTANT WIDE LINE OF LIGHT IN MIDDLE OF VISION. THE SYMPTOMS COULD NOT BE RESOLVED. REPORTEDLY LENS WITH MODEL Z9002 AND HIGHER DIOPTER OF +25.0 WAS USED AS REPLACEMENT FOR THE PATIENT. DURING THE PROCEDURE VITRECTOMY WAS REQUIRED. PATIENT REPORTED GOOD POST OPERATIVE OUTCOME WITH IMPROVED VISION. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Code Available; Visual Disturbances; Vitrectomy
MAUDE report 9895030 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.