TECNIS IOL ZA9003 (REF ZA90030295)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 05050474529205), received between Nov 3, 2023 and Nov 3, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED BY THE CUSTOMER THAT THE SECONDARY SULCUS LENS WAS CENTERED, BUT BY POST OP DAY 1, THE ENTIRE CAPSULAR BAG AND THE SULCUS INTRAOCULAR LENS HAD DISINSERTED INTO THE VITREOUS INFERIORLY. ADDITIONAL INFORMATION WAS REVEALED THAT IT WAS SCHEDULED FOR THE REMOVAL OF THE SULCUS LENS AND THE PLACEMENT OF ANOTHER GLUED LENS BY THE YAMANE TECHNIQUE. FURTHER INFORMATION RECEIVED REVEALED THAT A GLUE LENS WAS IN PLACE FOR A ZA9003 +30 DIOPTER AND THE PREVIOUS +29.50 DIOPTER LENS WAS REMOVED FROM THE EYE. NO FURTHER INFORMATION IS AVAILABLE..
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18069344 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page