TECNIS IOL DFW225 (REF DFW225U060)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474751576), received between Aug 31, 2022 and Jun 24, 2024 — classified as 2 injuries.

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.

• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED THAT A PATIENT HAS BLURRY VISION WITH A TORIC INTRAOCULAR LENS (IOL) AND THAT THE PATIENT DOES NOT HAVE VISION THEY ARE SATISFIED WITH. IT WAS INDICATED THAT THE PATIENT DID NOT LIKE THE FEELING OF FILMY VISION, EVEN WITH CORRECTION ( REFRACTIVE SE WAS -0.25). THE DOCTOR WAS PLANNING TO EXPLANT AND REPLACE THE IOL. THROUGH FOLLOW UPS, IT WAS LEARNED THAT THE EXPLANT OCCURRED ON (B)(6) 2024 AND THAT A JOHNSON & JOHNSON TORIC LENS OF DIFFERENT MODEL AND LOWER DIOPTER (DXW225 5.5D) WAS IMPLANTED IN THE PATIENT¿S LEFT EYE AS A REPLACEMENT. NO OTHER OCULAR ISSUES REPORTED. IT WAS NOTED THAT DURING THE LENS EXCHANGE THERE APPEARED TO BE QUITE A LOT OF CAPSULAR FIBROSIS AND EVEN SOME CONTRACTURE. NEVERTHELESS, THE EXCHANGE APPEARED TO BE SUCCESSFUL. THERE ARE NO OTHER PLANNED PROCEDURES. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 19602547 ↗
• 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; Blurred Vision; Dry Eye(s)

  MAUDE report 15331842 ↗