TECNIS IOL DFR00V (REF DFR00VU080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474750432), received between Aug 31, 2022 and Jan 12, 2024 — classified as 1 injury, 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2024Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED FROM THE LEFT EYE DUE CHIP OR CHUNK OF THE LENS WAS MISSING. THE PROCEDURE WAS COMPLETED USING LENS OF SAME MODEL. THE PATIENT IS DOING GOOD. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507976 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SURGEON HAS STOPPED USING THE SYNERGY INTRAOCULAR LENS (IOL) AND RATHER USES THE COMPETITOR'S LENS. THE SURGEON HAD SEVERAL CASES IN WHICH THE SYNERGY PATIENTS WERE NOT SATISFIED WITH THEIR DISTANCE VISION DESPITE WAITING SEVERAL MONTHS AFTER SURGERY. THE SURGERIES WERE UNCOMPLICATED AND THE SURGEON NOTED HE CAREFULLY EVALUATES ALL PATIENTS TO DETERMINE WHETHER THEY WOULD BE GOOD CANDIDATES FOR POSTERIOR CHAMBER INTRAOCULAR LENSES (PCIOL), HE REGULARLY ADDRESSES OCULAR SURFACE ISSUES, AND UNDERSTANDS PROPER TARGETING FOR REFRACTIVE OUTCOME AND IOL SELECTION WITH SYNERGY. FURTHER INFORMATION WAS PROVIDED THAT THE PATIENT HAD BILATERAL IMPLANTS. AT 4 WEEKS POST-OPERATIVE (OP), (B)(6) 2021, SC (WITHOUT CORRECTION) IN RIGHT EYE (OD) DISTANCE 20/20, SC NEAR J1+, AND SC INTERMEDIATE: J1. SC LEFT EYE (OS) DISTANCE: 20/40, SC NEAR: J1+, AND SC INTERMEDIATE: J3. MACULAR DRUSEN OS/FAINT ERM (EPIRETINAL MEMBRANE). NO ERM OD AT (B)(6) 2021 EXAM. THE PATIENT IS A GLAUCOMA SUSPECT LOW RISK OU (BOTH EYES) AND WAS DIAGNOSED PRIOR TO SURGERY. PATIENT WAS DIAGNOSED WITH KCS (KERATOCONJUNCTIVITIS SICCA=DRY EYE SYNDROME) OU AFTER THE IOL IMPLANTS. PATIENT VERY MYOPIC WITH AXL'S (AXIA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dry Eye(s)

  MAUDE report 15331895 ↗