TECNIS IOL DFW150 (REF DFW150U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474751323), received between Jan 5, 2022 and Sep 23, 2024 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WERE EXPLANTED FROM THE PATIENT'S RIGHT EYE. THE IOL WAS EXPLANTED BY ANOTHER PRACTICE. THE REASON FOR THE EXPLANT IS THE PATIENT REPORTED SEVERE HALOS AND GLARE AND WAS UNHAPPY. THE SYMPTOMS WERE DEBILITATING AS THE PATIENT COULD NOT DRIVE AT NIGHT. THE IOLS WERE REPLACED WITH A MONOFOCAL LENS. THE PATIENT'S PRE-OPERATIVE VISION WAS 20/30. POST-OPERATIVE VISION 20/30+. THE PATIENT IS DOING WELL AND HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20286775 ↗
• InjuryMar 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DUE TO PATIENT COMPLAINTS OF GLARE, HAZY VISION, AND STARBURST AT NIGHT, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS. DURING THE LENS EXCHANGE PROCEDURE, THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-PROCEDURE/LENS EXCHANGE WAS REPORTED AS DOING WELL AS OF DAY 1 POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Flashers; Visual Disturbances

  MAUDE report 18919062 ↗
• InjuryJan 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, AND IMMEDIATELY AFTER SURGERY THE PATIENT HAD TUNNEL VISION. ANOTHER DOCTOR PLACED A PIGGYBACK THINKING IT MIGHT BE A DYSPHOTOPSIA BUT VISION SEEMED WORSE. IT WAS STATED THAT THE EVENT WAS FROM A DIFFICULT PATIENT WHO HAD BEEN TO THREE (3) DIFFERENT DOCTORS SINCE THE IOL WAS IMPLANTED, AND THAT THE PIGGYBACK LENS IS MOST LIKELY NOT A JOHNSON AND JOHNSON IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 18530067 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF BLURRINESS, HAZY VISION, AND HALOS, VISION AFTER SURGERY 20/200, AND REPLACED WITH A BAUSCH + LOMB ANTERIOR CHAMBER LENS. THERE WAS NO VITRECTOMY. PATIENT VISION 1-DAY POST OPERATIVELY (OP) DISTANCE VISION WITH OUT CORRECTION 20/CF (COUNTING FINGERS) AT 6 FEET. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16943432 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A FAMILY MEMBER OF THE PATIENT THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE IOL BEING ¿WRONG¿ AND A ¿POOR FIT¿, CAUSING SERIOUS DISCOMFORT. THE PATIENT¿S SYMPTOMS STARTED IN (B)(6) 2021; THE IOL ¿NEVER FELT RIGHT¿. ANOTHER IOL WAS IMPLANTED AS REPLACEMENT. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN IF ANY MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE PATIENT IS DOING BETTER WITH THE NEW IMPLANTED IOL. THROUGH FOLLOW-UP WITH THE SURGEON'S OFFICE, IT WAS LEARNED THAT REASON THE IOL WAS EXPLANTED WAS DUE TO THE PATIENT BEING UNABLE TO TOLERATE THE IOL. A VITRECTOMY WAS PERFORMED ON (B)(6) 2023, PRIOR TO THE LENS EXCHANGE, FOR AN UNKNOWN REASON. IT WAS NOTED FROM A VISIT WITH ANOTHER DOCTOR ON (B)(6) 2023 THAT THE PATIENT HAS A HISTORY OF VISUAL FLOATERS IN THE RIGHT EYE, HOWEVER IT IS UNKNOWN IF THIS ISSUE WAS PRIOR TO OR AFTER THE INITIAL CATARACT SURGERY. A NON-JOHNSON AND JOHNSON LIGHT ADJUSTABLE LENS (+22.5D) WAS IMPLANTED AS REPLACEMENT. A SUTURE WAS REQUIRED. IT WAS NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. NO PATIENT INJURY WAS NOTED. STANDARD OF CARE MEDICATION WAS PROVIDED AFTE

  Patient problems: Blurred Vision; Discomfort; Eye Pain; Vitreous Floaters

  MAUDE report 16839809 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAS A PLANNED INTRAOCULAR LENS (IOL) EXCHANGE SCHEDULED FOR (B)(6) 2022. THE LENS WILL BE REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL (DIFFERENT MODEL, DFR00V, SAME DIOPTER OF 23.0D). MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT REQUESTING ADDITIONAL INFORMATION REGARDING THE COMPLAINT AND CONFIRM THAT THE PLANNED EXPLANT HAD BEEN PERFORMED, HOWEVER, NO RESPONSE WAS RECEIVED. THE DEVICE WAS RECEIVED FOR EVALUATION ON (B)(6) 2022, WHICH INDICATES THE LENS WAS EXPLANTED. A STICKER ON THE DEVICE SPECIMEN CUP STATES THE DATE OF SERVICE FOR THE EXPLANT WAS (B)(6) 2022. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 16189019 ↗
• InjuryDec 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW150 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DOCTOR REPORTS PATIENT HAS INTRACTABLE POSITIVE PHOTOPSIA. OVER THE LAST 5-6 MONTHS THE DOCTOR HAS TRIED EVERYTHING TO TRY TO RESOLVE THE PATIENT'S SYMPTOMS (INCLUDING SPECTACLE CORRECTION, PRK, AND PILOCARPINE EYEDROPS); BUT ULTIMATELY CONCLUDED THAT AN IOL EXCHANGE IS REQUIRED FOR A TORIC MONOFOCAL LENS; ZCU150 240. DIOPTER. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING PHOTOREFRACTIVE KERATECTOMY (PRK) WAS PERFORMED ON (B)(6) 2022 AND PILOCARPINE EYEDROPS WERE GIVEN (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING DFW150 IOL EXPLANT WAS PERFORMED (B)(6) 2022 AND REPLACED WITH A ZCU150 24.0 DIOPTER IOL. THERE WAS NO COMPLICATIONS, SUCH AS CAPSULAR TEAR, NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE PATIENT'S RIGHT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT'S LEFT EYE.

  Patient problems: Flashers

  MAUDE report 15955956 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO HALOS. ANOTHER JOHNSON & JOHNSON ZCU150 LENS (DIFFERENT MODEL AND SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT HAS RECOVERED. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 14270131 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD SYNERGY LENS ON HIS LEFT EYE. IT WAS NOTED THAT THE PATIENT DEVELOPED BLURRY DISTANCE VISION. THE DOCTOR THEN PERFORMED SOME LASIK ENHANCEMENT ON THIS PATIENT TO BRING THEIR VISION INTO OPTIMAL FOCUS. THEN THE PATIENT WAS NOTED TO DEVELOP POSTERIOR CAPSULAR OPACIFICATION. HENCE, YTTRIUM ALUMINUM GARNET (YAG) WAS PERFORMED. THERE WAS NO POST YAG PATIENT INJURY. PATIENT OUTCOME WAS GOOD. THE LENS REMAINS IMPLANTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 13797245 ↗
• InjuryJan 5, 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 OPERATIVE EYE DUE TO SUBJECTIVE POOR VISUAL QUALITY, GLARE, HALO, DYSPHOTOPSIA, AND THE PATIENT WAS VERY DISSATISFIED WITH OUTCOME. MEASURED ACUITY WAS GOOD: RANGING FROM 20/20 TO 20/30 AND J1-J2 VISION. REFRACTIVE ERROR MEASURED AT -0.25+0.50 X 012. RETINAL OPTICAL COHERENCE TOMOGRAPHY (OCT) AND CORNEAL SURFACE DID NOT ADEQUATELY EXPLAIN PATIENT SYMPTOMS. PATIENT FELT THAT HER VISION WAS LIKE LOOKING THROUGH VASELINE AND AFTER 2 MONTHS OF FAILED ADAPTATION, IT WAS DECIDED AN EXCHANGE WAS THE BEST COURSE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. SUSPECT IOL WAS REPLACED WITH MODEL ZCB00 23.0 D (B)(4). THERE WAS NO PATIENT POST-OPERATIVE (OP) INJURY. PATIENT IS IMPROVING POST-OP, SATISFIED WITH VISION AFTER EXCHANGE SO FAR. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Halo; Visual Disturbances

  MAUDE report 13173227 ↗