TECNIS IOL ZA9003 (REF ZA90030300)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS Acry 13.omm 6OPT MODC PMMA OPTIEG · 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 05050474529212), received between Mar 17, 2017 and Mar 17, 2017 — classified as 1 injury.
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
Patient problems
- 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.
InjuryMar 17, 2017Bent; Bent
IT WAS REPORTED THAT THE HAPTIC OF AN INTRAOCULAR LENS (IOL) CAME OUT BENT FROM THE CARTRIDGE. REPORTEDLY, THE LENS WAS INSERTED INTO THE EYE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE HAPTIC WAS PROBABLY BENT ON INSERTION INTO THE CARTRIDGE. THE LENS WAS REMOVED FROM THE PATIENT'S EYE AND SUCCESSFULLY REPLACED WITH A BACK-UP LENS, DURING THE SAME SURGICAL PROCEDURE. THE INCISION WAS ENLARGED AND ONE SUTURE WAS USED. THE PATIENT'S OUTCOME WAS REPORTED BEING GOOD. THE LENS WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Code Available
MAUDE report 6412300 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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