TECNIS IOL ZMA00 (REF ZMA00U0235)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 3- PIECE 6.0MM 23.5 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474536876), received between Apr 27, 2021 and Aug 13, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Device Dislodged or Dislocated1
- Difficult to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2024Break; Break
IT WAS REPORTED THAT A LENS DEFECT WAS NOTICED IN THE MULTIFOCAL INTRAOCULAR LENS (IOL) AFTER IT WAS IMPLANTED, AND THE LENS WAS PROMPTLY REMOVED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19977138 ↗InjuryJun 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PREMIUM INTRAOCULAR LENS (IOL) BECAME DISLOCATED EVEN WITH THE CAPSULAR TENSION RING (CTR) IN THEIR LEFT EYE. THERE WAS PLANNED VITRECTOMY. IT WAS LEARNED THAT THERE WAS DECREASE IN VISION TO 40/80. ORIGINAL LENS WAS THEN EXPLANTED AND WAS REPLACED WITH AN ANTERIOR CHAMBER INTRAOCULAR LENS (ACIOL) NON JOHNSON AND JOHNSON IOL. NO PATIENT POST-OP INJURY, NO CAPSULE TEAR REPORTED. PATIENT NOTED TO BE GOOD POST-OP. THE EXPLANTED IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 17167642 ↗InjuryApr 27, 2021Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT A MODEL ZMA00 INTRAOCULAR LENS(IOL) WAS PARTIALLY PLACED IN THE PATIENT'S RIGHT EYE AND REMOVED. VITRECTOMY WAS NEEDED. PROCEDURE WAS COMPLETED USING A NON JOHNSON AND JOHNSON SURGICAL VISION LENS. PATIENT WAS DOING GOOD. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11730328 ↗
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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