TECNIS IOL ZCU300 (REF ZCU300U130)Recalls & reported problems
Johnson & Johnson Surgical Vision, Inc. · TECNIS TORIC II 1-PC 13.0D CYL3.00 · Class 3 · Implant
All models of TECNIS IOL (1344)
Data updated Oct 18, 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 05050474660014), received between Oct 16, 2020 and Oct 16, 2020 — 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 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Material Fragmentation1
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.
InjuryOct 16, 2020Material Fragmentation; Device Dislodged or Dislocated; Material Fragmentation; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS SHEERED OFF UPON INSERTION INTO THE PATIENT'S RIGHT EYE. THE IOL WAS CENTERED AND HENCE DOCTOR LEFT IT IN THE EYE. DURING ONE DAY POST-OP EXAMINATION, IT WAS EXAMINED THAT THE IOL HAD DECENTERED. THE IOL WAS EXPLANTED AND A NEW LENS OF DIFFERENT MODEL (SN: (B)(4)) WAS IMPLANTED. THERE WAS NO INJURY TO THE PATIENT DURING THE PROCESS, HOWEVER, INCISION WAS ENLARGED WITH SUTURE PLACEMENT TO CLOSE THE WOUND. THE PATIENT IS DOING WELL POST-OP WITH UNCORRECTED VISION 20/25. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Code Available
MAUDE report 10691537 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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