TECNIS IOL DFW225 (REF DFW225U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474751873), received between Jan 14, 2022 and Apr 30, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DFW225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF DYSPHOTOPSIA AND REPLACED WITH AN AR40E 20.0 DIOPTER IOL. DUE TO SCLERAL TUNNEL BEING PLACED, INCISION ENLARGEMENT, SCLERAL SUTURES, AND PARS PLANA VITRECTOMY WERE PERFORMED DURING THE LENS EXCHANGE PROCEDURE. SCLERAL SUTURES AND PARS PLANA VITRECTOMY WERE BOTH PLANNED AND SUTURES WERE USED AS A PROPHYLACTIC MEASURE. THERE WAS NO PATIENT INJURY. PATIENT PROGNOSIS POST LENS EXCHANGE PROCEDURE WAS REPORTED AS GOOD RESULT, PATIENT HAPPY WITH THE RESULT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 21939903 ↗
• InjuryFeb 18, 2025Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT DRY EYE CAUSED AN ERRONEOUS TOPOGRAPHY, LEADING TO THE INCORRECT PERCEPTION OF A NEED FOR A TORIC LENS. HOWEVER, THE SURGEON INTRODUCED 2 DIOPTERS OF CYLINDER. INITIALLY, THE DOCTOR PLANNED TO REMOVE THE TORIC INTRAOCULAR LENS (IOL) AND REPLACE IT WITH A NON-TORIC SYNERGY OR ODYSSEY LENS. HOWEVER, ADDITIONAL INFORMATION SUGGESTS THAT THE DOCTOR OPTED TO ROTATE THE LENS INSTEAD OF REMOVING IT. THE ROTATION WILL BE MORE THAN 10 DEGREES, SPECIFICALLY FROM 138 DEGREES TO 165 DEGREES. AS OF THE PATIENT'S LAST VISIT, THEIR UNCORRECTED VISION IMPROVED FROM 20/80 TO 20/30 AFTER THE ROTATION, AND THE PATIENT SEEMS SATISFIED WITH THE OUTCOME. FURTHER INFORMATION SUGGESTS THAT THE ROTATION OCCURRED DUE TO A PLACEMENT ISSUE. NO FURTHER TREATMENT OR INJURIES WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT UPON POSTOPERATIVE EXAMINATION, THE PATIENT REPORTED COMPLAINTS OF DIPLOPIA AND SHADOWING AND THESE VISUAL COMPLAINTS HAVE PERSISTED FOR SEVERAL MONTHS. THE PATIENT STATES THAT THIS IS AFFECTING ALL OF HIS DAILY ACTIVITIES. THE DOCTOR WOULD LIKE TO EXCHANGE THE IOL FOR AN ODYSSEY TORIC LENS IMPLANT. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 21406588 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW225 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). COMPLAINTS OF BLURRED VISION, PHOTOPSIAS, GLARE, AND HALOS WERE NOTED POST-OPERATIVE DAY 1 ONWARD. BEST CORRECT VISION WAS REPORTED AS 20/25. THERE IS NO INDICATION THE PATIENT SYMPTOMS BEING REPORTED ARE DEBILITATING. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE DFW225 IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. THE EXPLANTED IOL WAS REPLACED WITH A DIU225 21.0 DIOPTER IOL. THERE WAS NO SERIOUS PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY HOWEVER THE INCISION WAS ENLARGED - 3.0MM. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS 20/40 UNCORRECTED ON POST OP-DAY 1. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 19102361 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE AND THEN EXPLANTED MONTHS LATER DUE TO THE PATIENT EXPERIENCING VERY BOTHERSOME HALOS AND GLARE WHEN DRIVING AT NIGHT, WHICH SEEMED WORSE AROUND RED LIGHTS. THE PATIENT REQUESTED TO HAVE THE IOL REMOVED. THE PROCEDURE WAS COMPLETED USING A COMPETITOR IOL (MODEL: LIGHT ADJUSTABLE). THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE. THE CURRENT PATIENT STATUS IS UNKNOWN. THE EXPLANTED IOL WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13642380 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT AFTER IMPLANTING THE JOHNSON & JOHNSON INTRAOCULAR LENS (IOL), THEIR PATIENT HAS HAD TWO RESIDUAL DIFFICULTIES. PATIENT HAS ALWAYS FELT THAT THERE WAS SIGNIFICANT GLARE, VISUAL DISTURBANCE WITH THE MULTIFOCAL LENSES. THIS HAS INTERFERED SIGNIFICANTLY WITH HER DRIVING ABILITY AS WELL AS ANY BRIGHT LIGHTS SITUATIONS. ADDITIONALLY, THE DOCTOR REPORTED THAT SHE HAS BEEN FOUND TO HAVE SOME IRREGULAR ASTIGMATISM AND SOME RESIDUAL NEARSIGHTEDNESS, PRESBYOPIA AFTER THE COUNTER ACTIVITY. FOR ALL OF THE MENTIONED REASONS AND AFTER A LONG DISCUSSION, THE DOCTOR DECIDED TO DO A LENS EXCHANGE OF THE LENS IN THE RIGHT EYE WITH A CONVENTIONAL LENS AIMING FOR DISTANCE VISION AND PLANNING TO GET GLASSES AFTERWARDS FOR A FINAL IMPROVED REFRACTION. THE REPLACEMENT LENS IS MODEL DIB00 19.5 DIOPTER. NO CAPSULE TEAR WAS REPORTED AND NO SURGICAL OR MEDICAL INTERVENTION SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE PATIENT OUTCOME POST-OP IS TO BE DETERMINED DURING THEIR POST-OP PERIOD. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 13262395 ↗