TECNIS IOL ZA9003 (REF ZA90030100)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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474528819), received between Feb 24, 2017 and Nov 19, 2024 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE NON PRE-LOADED ZA9003 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY, THE PATIENT HAD A SUBLUXATION/DISLOCATION OF THE LENS, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER ZA9003 10.0 DIOPTER IOL. SYMPTOMS PERSISTED FOR 4.5 YEARS. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS NO INCISION ENLARGEMENT, SUTURES, NOR VITRECTOMY. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. THE FOLLOWING ARE ALL UNKNOWNS: WHETHER PATIENT'S DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED, PROCEDURE DELAYS, MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), OR IF MEDICAL ATTENTION WAS REQUIRED. PATIENT STATUS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. PATIENT INFORMATION CANNOT BE PROVIDED DUE TO PERSONAL DATA PRIVACY LEGISLATION/POLICY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20720372 ↗MalfunctionFeb 24, 2017Scratched Material; Scratched Material
IT WAS REPORTED THAT THE DOCTOR PLACED THE INTRAOCULAR LENS (IOL) IN THE SULCUS DUE TO AN ANTERIOR RANT (NO VITREOUS LOSS). AFTER THE IOL WAS INJECTED, THE DOCTOR NOTICED A SCRATCH ON THE LENS. THE SCRATCH WAS OFF CENTER. AN EXPERIENCED TECHNICIAN LOADED THE LENS AND THE DOCTOR DOESN¿T BELIEVE THE TECHNICIAN DAMAGED THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6357001 ↗
Other intraocular lens devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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