TECNIS IOL ZMA00 (REF ZMA00U0220)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS MF 3- PIECE 6.0MM 22.0 US · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 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 05050474536845), received between Jun 14, 2018 and Oct 28, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Bent” (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.
Most reported problems
Device problems
- Bent1
- Break1
- Material Deformation1
- Scratched Material1
Patient problems
- No Code Available1
- Vitrectomy1
- Zonular Dehiscence1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2021Break; Break
IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AS THE HAPTIC WAS BENT. THE PATIENT HAD TORN ZONULES DUE TO THE ISSUE. VITRECTOMY WAS PERFORMED AND AN ANTERIOR CHAMBER LENS WAS PLACED AS THE REPLACEMENT AFTER ENLARGING THE INCISION. THE PATIENT STATUS WAS FAIR POST-OPERATION. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Zonular Dehiscence
MAUDE report 12716131 ↗InjurySep 25, 2018Material Deformation; Material Deformation
IT WAS REPORTED THAT THE HAPTICS OF THE INTRAOCULAR LENS (IOL) WERE CRINKLED DURING IMPLANTATION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT ONLY THE CARTRIDGE TOUCHED THE EYE. REPORTEDLY A VITRECTOMY WAS PERFORMED AND SUTURES WERE USED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Vitrectomy
MAUDE report 7905021 ↗InjuryJun 14, 2018Bent; Scratched Material; Bent; Scratched Material
IT WAS REPORTED THAT DURING INSERTION INTO THE EYE, THE INTRAOCULAR LENS ZMA00 +22.0 DIOPTER HAD A BENT HAPTIC AND THE LENS WAS SCRATCHED. THE INCISION WAS ENLARGED TO REMOVE THE LENS. ANOTHER ZMA00 WAS IMPLANTED AS A REPLACEMENT DURING THE SAME SURGICAL PROCEDURE. NO SUTURES WERE USED AND NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHNSON SURGICAL VISION, INC.
Patient problems: No Code Available
MAUDE report 7600514 ↗
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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