TECNIS IOL DFW150 (REF DFW150U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474751293), received between Jan 3, 2022 and Nov 5, 2024 — classified as 11 injuries, 3 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL LENS WAS IMPLANTED. DURING THE ATTEMPT TO CENTER IT IN THE CAPSULAR BAG, SURGEON NOTICED THAT PART OF ONE OF THE HAPTICS WAS MISSING. THE LENS WAS SUBSEQUENTLY EXPLANTED AND THE BACKUP LENS WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612979 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED WITH ANOTHER TORIC LENS OF DIFFERENT MODEL ZCU225 BUT OF THE SAME DIOPTER (21.5 D). THE REASON FOR THE EXPLANT WAS NOT SPECIFIED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19356476 ↗
• InjuryOct 20, 2023Adverse 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 DEXTER (RIGHT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF POOR MULTIFOCAL NEURO ADAPTATION. PATIENT REPORTED COMPLAINTS OF DIFFICULTY DRIVING AT NIGHT DUE TO GLARE, LIGHT SENSITIVITY, AND HALOS. THE EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION IOL, DIOPTER SIZE IS UNKNOWN. THERE WAS NO PATIENT INJURY, NO SUTURES, AND NO VITRECTOMY HOWEVER THE INCISION WAS ENLARGED. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17981271 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT FEELS DISTANCE VISION (DV) NOT CRISP IN BOTH EYES (OCULUS UTERQUE -OU), EVEN THOUGH HIS REFRACTION AFTER INITIAL SURGERY PL-0.25X37 20/20. ALSO PATIENT CAN NO LONGER SEE GOLF BALL AT A DISTANCE POST INITIAL CATARACT SURGERY. IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCT150 20.5 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, NO MEDICAL ATTENTION, AND NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE). BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE: 20/60 AND BCVA POST-OPERATIVE: 20/20. PATIENT OUTCOME POST-PROCEDURE: BEST UNCORRECTED DV AT 1 DAY POST-OP 20/40+1. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 17014945 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE JNJ IOL WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE IOL WAS EXPLANTED BECAUSE THEY COULD NOT SEE STREET SIGNS UNLESS THEY WERE UP CLOSE. REPORTEDLY, SHE STARTED LOSING DISTANCE VISION. SHE ALSO SAW SHADOWS AND LOST CONTRAST IN COLORS AS THOUGH SHE HAD LOST 10% OF BLACK IN HER VISION. SHE HAS DIFFICULTY READING HER COMPUTER AND WHEN SHE COVERS ONE EYE THE OTHER OBJECTS APPEAR TO BE IN DIFFERENT PLACES. CONSEQUENTLY THE PATIENT DID NOT FEEL COMFORTABLE WALKING AS SHE WAS AFRAID TO FALL. PATIENT WANTED TO COVER HER EYE WITH A PATCH BUT WAS CONCERNED IF IT WOULD STRAIN HER OTHER EYE. SHE ALSO INQUIRED ABOUT POSSIBLE ISSUE WITH HAVING THE IOL EXPLANTED. SHE WAS ADVISED TO FOLLOW-UP WITH HER DOCTOR. REPORTEDLY, THE DOCTOR INFORMED HER SHE HAS SMALL PUPILS. SHE HAS NO OTHER EYE HEALTH ISSUES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Corneal Edema; Visual Disturbances

  MAUDE report 16196818 ↗
• InjurySep 20, 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 A PATIENT'S RIGHT EYE AS THE PATIENT FELT LIKE HE WAS LOOKING THROUGH A THIN LAYER OF VASELINE AND COMPLAINED OF BLURRY VISION ESPECIALLY AT A DISTANCE. THE PATIENT HAD DEBILITATING CONDITION AND COMPLAINED THAT HIS COMPUTER SCREEN WAS "FUZZY" AND COULD NOT READ WELL. A NON-JOHNSON AND JOHNSON LENS WAS USED AS THE REPLACEMENT IOL. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THE PATIENT IS DOING WELL POST-OP AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15458810 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW150 21.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS HIS DAY VISION IS GOOD, (20/20 IN ONE EYE AND 20/25 OR 20/30 IN THE OTHER), HE IS UNABLE TO DRIVE AT NIGHT BECAUSE OF GLARE, AND HALOS. HE DESCRIBED THE HALOS IN TERMS OF FEET AROUND LIGHTS, WITH SPARKS OF WHITE LIGHTS, THAT MAKE HIM FEEL UNSAFE DRIVING AT NIGHT. HE DOES NOT DRIVE AT NIGHT ANYMORE AND IS UNHAPPY ABOUT THIS. PATIENT HAS DISCUSSED HIS VISUAL ISSUES WITH HIS DOCTOR AND HAS HAD SECOND OPINIONS. ALL HAVE TOLD HIM THAT THE LENS IS IMPLANTED CORRECTLY AND THAT THERE ARE NO PHYSICAL ISSUES THAT CAN BE DETECTED. HIS EYES WERE HEALTHY AND THEY ARE IN ALIGNMENT. IN ADDITION, HE NO LONGER NEEDS TO USE READERS. THE DOCTOR DETECTED A FILM ON EYES AND A LASER YTTRIUM ALUMINUM GARNET (YAG) WAS CONDUCTED TO CLEAN THE LENS, APPROXIMATELY 2 WEEKS AGO. PATIENT ALSO PROVIDED A DIAGRAM WHERE HE REPORTS BEFORE AND AFTER THE YAG PROCEDURE GLARE IS 360 DEGREES. GLARE IS 8' TO 12' DIAMETER. STOPLIGHT GLARE IS 4' TO 6' DIAMETER. HEADLIGHTS ARE 3' TO 5' DIAMETER AND CANNOT SEE THROUGH GLARE TO SEE WHERE FENDER OF CAR IS. ALL CIRCLES HAVE 8 RINGS OF LIGHT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Flashers; Halo; Visual Disturbances

  MAUDE report 14275120 ↗
• MalfunctionMar 14, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS DAMAGED IN THE INJECTOR AND THERE WAS PATIENT CONTACT. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, TO DATE A RESPONSE HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13759382 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT AFTER IMPLANTING A JOHNSON & JOHNSON (JNJ) INTRAOCULAR LENS (IOL) INTO THE PATIENT'S RIGHT EYE, THEY EXPERIENCED BLURRY VISION. THE PATIENT COMPLAINT ABOUT BLURRY VISION IN THEIR RIGHT EYE, VISION IN TWO EYES DOES NOT MATCH. THE IOL WAS EXPLANTED FROM THEIR RIGHT EYE. THE CUSTOMER EXPLAINED THAT THEY DID NOT HAVE A JNJ IOL IN STOCK SO THEY WENT WITH A DIFFERENT MANUFACTURER. THE PATIENT'S LEFT EYE IS FINE AND THERE ARE NO ISSUES WITH THAT EYE. IT WAS INDICATED THAT THERE WERE NO COMPLICATIONS SUCH AS CAPSULE TEAR, VITRECTOMY, SUTURES OR MEDICATIONS OUTSIDE THE REGULAR STANDARD OF CARE WITH THE INITIAL IMPLANTED LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 13691637 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, THE PATIENT EXPERIENCED "NIGHT BLINDNESS" WHEN DRIVING AT NIGHT, WITH LIGHTS THAT WERE "SO INTENSE" THE PATIENT WAS UNABLE TO SEE ANYTHING AND BARELY MADE IT HOME. THE PATIENT REPORTED THE ON-COMING HEADLIGHTS AND STREETLIGHTS HAD A GLARE WITH 7 RINGS AROUND THE LIGHTS. THE PATIENT REPORTED BEING SCARED AND UNABLE TO DRIVE AT NIGHT NOW DUE TO NOT BEING ABLE TO SEE BECAUSE OF THE LIGHTS. THE PATIENT LOVES THE IOL DURING THE DAY AND DOES NOT NEED TO WEAR READING GLASSES. THE PATIENT REPORTED THERE IS "BLURRINESS" TO THE RIGHT OF THE IOL BECAUSE "THE LENS DOESN'T COVER THE WHOLE EYEBALL." THE PATIENT'S DOCTOR ADVISED THAT MORE TIME IS NEEDED TO SEE IF THE PATIENT'S ISSUES IMPROVE. THROUGH FOLLOW-UP WITH THE PATIENT'S DOCTOR, IT WAS REPORTED THAT THE PATIENT'S VISION AT ONE WEEK POST-OP WAS 20/20 NEAR AND 20/25 DISTANCE. THE DOCTOR INFORMED THE PATIENT THAT THE EYE STILL NEEDS TO ADAPT TO THE IOL, WHICH COULD BE CONTRIBUTING TO THE INCREASED GLARE. THERE WERE NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. THERE IS NO PLANNED INTERVENTIONS. THE IOL REMAINS IMPLANTED IN THE EYE. NO

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13664991 ↗
• InjuryFeb 23, 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 RIGHT EYE DUE TO MILD MYOPIC MISS, LOOKED FOGGY, WITH YTTRIUM ALUMINUM GARNET (YAG) DONE PRIOR TO EXPLANT. EXPLANTED IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO PATIENT POST-OP INJURY. THE PATIENT IS FINE POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 13582658 ↗
• MalfunctionJan 27, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, IT WAS REMOVED AND REPLACED WITH ANOTHER LENS OF SAME MODEL AND DIOPTER AS THE ORIGINAL LENS WAS TORN. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH PATIENT¿S ACTIVITIES OF DAILY LIFE AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13376757 ↗
• InjuryJan 7, 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 FULLY INSERTED IN THE PATIENT'S RIGHT EYE. BUT THE PATIENT WAS BROUGHT BACK TO SURGERY TO EXPLANT THE IOL AND BE REPLACED WITH A NEW IOL. THE REPLACEMENT IOL WAS ANOTHER JOHNSON & JOHNSON LENS DFR00V, 21.5D. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 13198854 ↗
• InjuryJan 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE 21.5 DIOPTER PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO MYOPIC MISS. ANOTHER LENS OF SAME MODEL BUT LOWER DIOPTER (21.0) WAS IMPLANTED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTIONS WERE REQUIRED. THE PATIENT WAS DISCHARGED, AND THERE IS NO UPDATE ON HOW SHE WAS DOING POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 13147556 ↗