TECNIS IOL ZA9003 (REF ZA90030270)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
- 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 05050474529151), received between May 19, 2018 and May 27, 2021 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2021Break; Break
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD BENT/BROKEN HAPTIC DURING YAMANE TECHNIQUE. THE IOL WAS FULLY INSERTED AND THEN IMMEDIATELY REMOVED THROUGH THE ORIGINAL INCISION AND REPLACED DURING THE SAME PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11891824 ↗InjuryFeb 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO A REFRACTIVE SURPRISE. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER, 23.5 ) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 11347183 ↗InjuryMay 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A ZA9003 INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2018 AND WAS SUBSEQUENTLY EXPLANTED ON (B)(6) 2018. PER ACCOUNT, THE PHYSICIAN DECIDED TO CHANGE THE LENS POWER. AT EXPLANT, NO INCISION ENLARGEMENT WAS REQUIRED AND THERE WAS NO PATIENT INJURY. THE PATIENT WAS NOTED TO BE RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Code Available
MAUDE report 7528585 ↗
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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