TECNIS IOL DFW150 (REF DFW150U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474751231), received between Jan 27, 2022 and Dec 4, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DFW150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). POST-OPERATIVELY UNSPECIFIED VISUAL ISSUES WERE OBSERVED; THUS, THE IOL WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE. INFORMATION ABOUT THE REPLACEMENT IOL AND PATIENT PROGNOSIS POST LENS EXCHANGE ARE BOTH UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 23722783 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED THAT THE INTRAOCULAR LENS HAD BEEN IMPLANTED AFTER CATARACT SURGERY ON HER RIGHT EYE ON (B)(6) 2023 AND HAD A DFW150 INTRAOCULAR LENS (IOL) PLACED. THE PATIENT WAS INTENSELY BOTHERED BY GLARE, SO ANOTHER SURGEON PERFORMED THE LENS EXCHANGE ON (B)(6) 2024 WITH ANOTHER MONOFOCAL IOL. ADDITIONAL INFORMATION SUGGESTS THAT THE PATIENT IS DOING WELL AND REFRACTS TO 20/40 WITH ADVANCED POSTERIOR CAPSULAR OPACIFICATION THAT WILL REQUIRE A YAG LASER. FURTHER INFORMATION SUGGEST THERE WAS NO YAG PERFORMED, BUT SHE WILL REQUIRE A YAG CAPSULOTOMY IN THE FUTURE FOR THE CLOUDINESS OF HER POSTERIOR CAPSULE. SHE HAS ANOTHER APPOINTMENT SCHEDULED (B)(6) 2024 AND DOCTOR MAY DO THE YAG CAP AT THAT TIME. THERE WAS NO INJURY. THE PRODUCT IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 19735693 ↗
• InjuryJun 7, 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). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF GLARE 90% OF THE TIME, COLORS DULL, FILM OVER VISION, AND "NEVER GOOD" VISION. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCU150 19.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE NO SERIOUS INJURY, NO SUTURE(S), AND NO VITRECTOMY. IT IS UNKNOWN IF THE INCISION WAS ENLARGED. PATIENT'S POST-LENS EXCHANGE OUTCOME WAS REPORTED AS PATIENT HAPPY WITH VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17084127 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD CATARACT PROCEDURE AND INTRAOCULAR LENS WAS IMPLANTED IN THE LEFT EYE. ON DAY ONE POST OPERATIVE EXAMINATION ON (B)(6) 2022, PATIENT COMPLAINED OF NOTICING HALOS SINCE SURGERY WHICH WAS WORSE AROUND LIGHTS. THE PATIENT WAS ADVISED TO CONTINUE USING PREDNISOLONE/GATIFLOXACIN FOUR TIMES A DAY. ON THE SECOND POST OPERATIVE VISIT ON (B)(6) 2022, PATIENT STATED THAT THE DISTANCE VISION WAS NOT AS CLEAR AS SHOULD BE AND THERE WAS "BARRIER" IN THE VISION IN THE LEFT EYE. SHE WAS HAVING LIGHT SENSITIVITY. THE ASSESSMENT OF THE SURGEON WAS THAT THE EYE WAS HEALING WELL. ON THE THIRD POST OPERATIVE VISIT ON (B)(6) 2022, PATIENT STATED THAT SHE SEES HALOS AROUND LIGHTS AT NIGHT AND THE BRIGHT LIGHTS ARE BOTHERSOME. PATIENT FELT SOMETHING IN THE EYE WHICH DOES NOT IRRITATE, HOWEVER, WAS NOT SURE HOW TO DESCRIBE IT. THE PATIENT FELT LIKE THE DISTANCE VISION CAN BE IMPROVED. PATIENT WAS ADVISED TO CONTINUE PREDNISOLONE/GATIFLOXACIN TWICE A DAY UNTIL DROPS ARE FINISHED. ON FURTHER FOLLOW UP ON (B)(6) 2023, PATIENT WAS SEEING HALOS AND STARBURSTS AROUND LIGHTS AT NIGHT, AND WAS SENSITIVE TO SUNLIGHT. BOTH EYES WERE EXTREMELY DRY (THE OTHER EYE STILL HAD NATURAL CAT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Eye Pain; Flashers; Foreign Body Sensation in Eye; Halo; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment

  MAUDE report 16455552 ↗
• InjuryOct 6, 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 BOTH EYES AS THE PATIENT WAS NOT HAPPY WITH THE RESULTS. THE PATIENT WAS UNHAPPY WITH THE "MOTION SICKNESS/HEADACHES/EXTREME LIGHT SENSITIVITY" DURING POST-OP WEEK 6 FOLLOW-UP EXAMINATION. HE HAD COMPLAINED ABOUT THESE SYMPTOMS EARLIER IN THE POSTOPERATIVE PERIOD WITH HIS REFERRING OPTOMETRIST (POSTOP WEEK 1-3). THE PRE-OPERATIVE VISUAL ACUITY WAS +2.75 -1.00 X 100: 20/30-2 AND THAT AFTER THE IMPLANTATION WITH THE ORIGINAL LENS WAS -0.25 -1.00 X 029: 20/20. ANOTHER COMPETITOR LENS OF SAME DIOPTER WAS USED AS THE REPLACEMENT AND VISUAL ACUITY POST REPLACEMENT WAS -0.50 SPH 20/20. THE PATIENT IS NOW HAPPY AND VISUAL COMPLAINTS HAVE COMPLETELY RESOLVED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE LENS EXPLANTED FROM RIGHT EYE AND A SEPARATE REPORT HAS BEEN ALREADY FILED FOR THE LENS EXPLANTED FROM LEFT EYE.

  Patient problems: Headache; Insufficient Information; Visual Disturbances

  MAUDE report 15556806 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED OF UNHAPPY PATIENTS DUE TO NIGHTTIME GLARE AND HALO WITH SYNERGY INTRAOCULAR LENS (IOL). THE PATIENT WENT FOR A SECOND OPINION TO ANOTHER DOCTOR AND THAT DOCTOR TOLD THE PATIENT THAT THE SURGEON DID A NICE JOB WITH THE SURGERY, THAT HIS ISSUE HAS TO BE THE LENS IMPLANTED WAS A ¿DUD¿ AND OFFERED TO EXPLANT THE LENS TO BE REPLACED WITH A COMPETITOR IOL. THE PATIENT WENT BACK TO THE ORIGINAL SURGEON WHO TOLD THE PATIENT THAT THE ISSUE WAS NOT THE LENS IMPLANT BUT THAT HE HAS FLOATERS. ACCORDING TO THE SURGEON, THE PATIENT KNEW THIS GOING INTO THE PREMIUM DECISION AND UNDERSTOOD HE MAY NOT GET THE FULL OUTCOME DUE TO RETINAL ISSUES. CONSEQUENTLY, THE IOL WAS EXPLANTED FROM THE PATIENT'S LEFT EYE BY THE ORIGINAL SURGEON. NO FURTHER INFORMATION WAS PROVIDED. THIS EMDR CAPTURES THE EVENT REPORTED WITH THE SECOND PATIENT. A SEPARATE REPORT WAS SUBMITTED FOR THE FIRST PATIENT.

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

  MAUDE report 14682226 ↗
• InjuryMar 15, 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 THE PATIENT WAS EXPERIENCING UNBEARABLE GLARE AND HALO 6 WEEKS POST-OPERATIVE (OP AND ESPECIALLY AT NIGHT. THE INCISION WAS ENLARGED. IT WAS ALSO REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY DRIVING AT NIGHT. PRE-OPERATIVE VISUAL ACUITY IS 20/60 DV CC (DV-DISTANCE VISION, CC-WITH CORRECTION). THE EXPLANTED IOL WAS REPLACED WITH ANOTHER J&J LENS MODEL ZCU150 18.5 DIOPTER (DIFFERENT MODEL, SAME DIOPTER). POST-OPERATIVE VISUAL ACUITY IS 20/25 -1 DV AND 2025 NV SC (NV-NEAR VISION, SC-WITHOUT CORRECTION). REPORTEDLY, THERE WAS NO VITRECTOMY AND NO SUTURES WERE REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13773598 ↗
• InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO HYPEROPIC MISS. ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 13373944 ↗