TECNIS IOL DFR00V (REF DFR00VU130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474750531), received between Dec 8, 2021 and Jan 13, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (2 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THE DFR00V WAS INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) WHEN A SCRATCH WAS NOTED BY THE SURGEON. THE IOL WAS PREPARED APPROPRIATELY BY THE TECHNICIAN IN THE ROOM WITH BALANCED SALT SOLUTION (BSS). IOL WAS REMOVED WITH MICRO SURGICAL TECHNOLOGY (MST) FORCEPS AND REPLACED WITH BACK UP LENS, WHICH WAS THE SAME MODEL AND DIOPTER SIZE. NO ADVERSE EFFECTS HAVE BEEN NOTED BY THE DOCTOR. THE DFR00V IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING NO UNPLANNED INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE WAS REPORTED AS: NO ADVERSE EFFECTS NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162466 ↗
• MalfunctionOct 31, 2022Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE SURGEON NOTICED A SCRATCH. THE SURGEON DID NOT SEE A DEFECT IN THE LENS PRIOR TO INSERTION. THE SURGEON BELIEVES A PART OF THE INSERTER BROKE OFF AND SCRATCHED THE LENS. THE IOL WAS FULLY INSERTED AND THEN REMOVED AND REPLACED WITH ANOTHER JOHNSON & JOHNSON IOL (SAME MODEL AND DIOPTER). THERE WAS NO PATIENT INJURY. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE TIP OF THE INSERTER WAS DAMAGED. IT WAS NOT COMPLETELY BROKEN OFF AND WAS STILL ATTACHED TO THE INSERTER LIKE A HANGNAIL. THE LENS WAS SCRATCHED IN TWO SEPARATE AREAS IN THE MIDDLE. WHEN THE SCRUB INSPECTED THE INSERTER WHEN LOADING, THERE WAS NO DEFECT. BEFORE INSERTING THE IOL, THE SURGEON DID NOT SEE A DEFECT UNDER THE MICROSCOPE. IT WAS AFTER SEEING THE SCRATCHES AND INSPECTING THE INSERTER AFTER INSERTION THAT THE WAS THE DEFECT NOTICED. NO OTHER SURGICAL/MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15705362 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO EXPERIENCING BLURRY VISION AND STAR BURSTS AT NIGHT. THERE WAS NO PATIENT INJURY REPORTED. ACCOUNT INDICATED THAT THE PATIENT'S VISUAL ACUITY 2 WEEKS POST SURGERY WAS 20/25. THE PATIENT WAS REPORTEDLY DOING GOOD AND CAN READ WITH OVER THE COUNTER READERS. THE EXPLANTED IOL IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers

  MAUDE report 14691794 ↗
• InjuryFeb 2, 2022Adverse 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 LEFT EYE DUE TO PATIENT COMPLAINING OF DYSPHOTOPSIA. THE SUSPECT IOL WAS REPLACED IT WITH A DIB00 12.5 DIOPTER POWER. IT WAS NOTED THAT THERE WAS INCISION ENLARGEMENT. THERE WAS NO PATIENT INJURY REPORTED. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN. AT 2-WEEK POST-OP IOL EXCHANGE PATIENT'S VISUAL ACUITY IS 20/25. THE PATIENT IS DOING WELL ENOUGH POST-EXPLANT, THAT THE DOCTOR RECOMMENDED CATARACT SURGERY ON FELLOW EYE. NO OTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 13421347 ↗
• MalfunctionJan 21, 2022Break; Break

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS INSERTED IN THE RIGHT EYE, IT WAS NOTICED THAT IT WAS CRACKED. IT IS UNKNOWN IF THE HAPTIC OR OPTIC WAS CRACKED. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED (SAME MODEL AND DIOPTER). NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13321308 ↗
• InjuryDec 8, 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 LEFT EYE DUE TO HALOS AND GLARES. A NON-JOHNSON & JOHNSON LENS WAS USED AS THE REPLACEMENT. THE INCISION WAS SLIGHTLY ENLARGED; HOWEVER, NO SUTURES WERE REQUIRED. THE PROCEDURE WAS COMPLETED AS PLANNED AND NO PATIENT INJURY WAS REPORTED. IT WAS INDICATED THAT THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12965348 ↗