TECNIS IOL ZMA00 (REF ZMA00U0140)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 3- PIECE 6.0MM 14.0 US · 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 05050474536685), received between Sep 28, 2018 and Mar 19, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Device Dislodged or Dislocated2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) DISLOCATED IN THE PATIENT¿S LEFT EYE. THE SURGEON INITIALLY PLANNED ON EXPLANTING THE IOL. HOWEVER, THE DOCTOR WAS ABLE TO REPOSITION THE IOL IN THE PATIENT'S EYE AND DID NOT EXPLANT OR EXCHANGE THE LENS AFTER ALL. THERE WERE NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21649110 ↗InjurySep 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A ZMA00 14.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. REPORTEDLY, THE DOCTOR TRIED SEVERAL TIME TO REPOSITION THE LENS, BUT THE LENS WOULD NOT STAY CENTERED, THEREFORE THE LENS WAS EXPLANTED ON (B)(6) 2018 REPLACEMENT LENS WAS A COMPETITOR LENS. THE PATIENT WAS REPORTED DOING GOOD. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 7917810 ↗
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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