TECNIS IOL ZMA00 (REF ZMA00U0075)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 3- PIECE 6.0MM 7.5 US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 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 05050474536555), received between Aug 22, 2017 and Aug 22, 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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blurred Vision1
- 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.
InjuryAug 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL ZMA00 7.5 DIOPTERS, WAS IMPLANTED ON (B)(6) 2016. THE PATIENT RETURNED ON (B)(6) 2017 TO REPOSITION THE LENS DUE TO BLURRY VISION. THE DOCTOR REPORTED THAT HE FEELS HE DAMAGED THE LENS BY SCRATCHING IT DURING THE REPOSITIONING PROCEDURE. THEREFORE, THE PATIENT RETURNED (B)(6) 2017 TO HAVE THE LENS EXPLANTED AND HAD ANOTHER LENS OF THE SAME LENS MODEL AND DIOPTER IMPLANTED. PATIENT IS DOING FINE. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY DURING THE EXPLANT. THE PRODUCT WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Blurred Vision; No Code Available
MAUDE report 6812175 ↗
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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