TECNIS IOL DFW150 (REF DFW150U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474751255), received between Feb 14, 2022 and May 10, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 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 DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF HALOS, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON IOL. THE INCISION WAS ENLARGED HOWEVER, THERE WAS NO DELAY IN PROCEDURE, NO SUTURES, AND NO VITRECTOMY. VISUAL ACUITY WAS 20/40 PRE-OPERATIVE AND 20/20 POST-OPERATIVE. PATIENT PROGNOSIS POST-LENS EXCHANGE WAS REPORTED AS DOING WELL AFTER IOL EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 19287936 ↗
• InjuryFeb 1, 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). PATIENT REPORTS COMPLAINTS OF DECREASED VISION. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS EXPLANTED DURING A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIU150 21.0 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO SERIOUS PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY. PATIENT STATUS POST IOL EXCHANGE WAS REPORTED AS 20/20 VISION AND PATIENT IS HAPPY WITH VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 18627903 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYNERGY SIMPLICITY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DURING SECONDARY SURGERY DUE TO THE PATIENT STILL SUFFERING FROM GLARE AND HALOS WHILE DRIVING AND HER VISION NOT BEING AS SHARP AS SHE WOULD LIKE IT TO BE FOR VISION. THERE WAS NO INFORMATION ABOUT INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY. THE LENS WAS REPLACED WITH ANOTHER J&J DIFFERENT MODEL, BUT WITH THE SAME DIOPTER. THE PATIENT'S POST-PROCEDURE STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18104288 ↗
• InjuryOct 13, 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 SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION IOL, DIOPTER SIZE IS UNKNOWN. THERE WAS NO PRODUCT QUALITY ISSUE WITH THE IOL HOWEVER THE REASON WHY THE EXPLANT WAS PERFORMED WAS NOT PROVIDED. THERE WAS NO VITRECTOMY HOWEVER, IT IS UNKNOWN IF INCISION ENLARGEMENT, SUTURE(S), MEDICAL ATTENTION WAS REQUIRED, OR IF MEDICATION WAS PRESCRIBED OUTSIDE OF STANDARD CARE. PATIENT OUTCOME POST-LENS EXCHANGE IS ALSO UNKNOWN. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 17933144 ↗
• InjuryOct 5, 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 THE PATIENT'S LEFT EYE. THE PATIENT STATED THAT HE FELT AS IF HE WAS LOOKING THROUGH A TUNNEL THROUGH THIS OPERATIVE EYE AND THE VISION WAS FUZZY. THE GLARE FROM THE HEADLIGHTS WAS A DISTRACTION AS HE IS SEEING THREE LINES THAT BLEND. DURING THE FIRST POST-OPERATIVE VISIT AFTER ORIGINAL IMPLANTATION, PATIENT STATED THAT BOTH EYES BOTHERED HIM DRIVING AT NIGHT DUE TO GLARE AND IT WAS OVERWHELMING. IT ALSO CAUSED OCULAR PAIN. HE ADDED THAT HIS ONLY JOB WAS UBER SINCE HE WAS UNEMPLOYABLE AND WAS UNABLE TO WORK DRIVING FOR UBER AT NIGHT. THE PRE-OPERATIVE VISUAL ACUITY WAS DSC OD 20/25 OS 20/25 -2 BAT: 20/200 OU AND AFTER LENS IMPLANTATION HIS VISUAL ACUITY WAS DSC OD 20/20 OS 20/40 -2 PH: 20/25 -2. NO OTHER INTERVENTION WAS PERFORMED. ANOTHER MONOFOCAL LENS OF DIFFERENT MODEL BUT OF SLIGHTLY HIGHER SPHERICAL DIOPTER (20D) WAS USED AS THE REPLACEMENT IOL. DURING POST-OPERATIVE EXAMINATION AFTER THE EXPLANT, PATIENT REPORTED DOING VERY WELL, AND NOTICING INSTANTLY THE DIFFERENCE WITH THE REPLACEMENT MONOFOCAL LENS WITH VISUAL ACUITY BEING 20/15. THE ORIGINAL LENS WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED

  Patient problems: Blurred Vision; Eye Pain; Visual Disturbances

  MAUDE report 15547243 ↗
• InjuryAug 26, 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 LEFT EYE 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 +3.00 -1.00 X 075 20/25. GLARE 20/100 AND THAT AFTER THE IMPLANTATION WITH THE ORIGINAL LENS WAS PLANO -1.00 X 014 20/20-3. THE PATIENT WAS UNHAPPY DESPITE BEST CORRECTED VISION WITH MR. ANOTHER COMPETITOR LENS OF SAME DIOPTER WAS USED AS THE REPLACEMENT AND VISUAL ACUITY POST REPLACEMENT WAS -0.50 SPHERICAL 20/20. THE PATIENT IS NOW HAPPY AND VISUAL COMPLAINTS HAVE COMPLETELY RESOLVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Headache; Insufficient Information; Visual Disturbances

  MAUDE report 15307582 ↗
• InjuryMay 4, 2022Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SYNERGY TORIC INTRAOCULAR LENS (IOL ) WAS UNHAPPY WITH THEIR VISION. THE SURGEON SAID THE LENS IS CENTERED IN THE BAG, BUT THAT IT IS NOT CENTERED ON THE PATIENT¿S PUPIL. HE BELIEVES THIS IS THE SOURCE OF PATIENT¿S DISSATISFACTION. THROUGH FOLLOW-UP, IT WAS LEARNED THE PATIENT EXPERIENCED GLARE, HALOS, AND HEADACHE. ADDITIONALLY, ON INITIAL INSERTION, A CRACK LINE WAS NOTED AT THE HAPTIC OPTIC JUNCTION. DECISION TO LEAVE LENS IN PLACE WAS MADE AND DID NOT APPEAR TO AFFECT LENS POSITION IN THE LEFT EYE. BUT AT POST-OPERATIVE (OP) VISIT, THE IOL WAS SLIGHTLY DECENTERED. SURGEON ATTEMPTED A SIMPLE REPOSITION WHICH FAILED, THEREFORE, THE DECISION WAS MADE TO EXCHANGE THE IOL. THE INCISION WAS ENLARGED, HOWEVER, SUTURES AND A VITRECTOMY WERE NOT REQUIRED. VISION PRE-OP 20/40; VISION POST-EXPLANT 20/25 AND J1. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 14283659 ↗
• InjuryApr 14, 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 DUE TO SIGNIFICANT AND CONTINUED VISUAL ISSUES OF GLARES AND HALOS. THE REPLACEMENT IOL WAS A DIFFERENT JOHNSON AND JOHNSON MODEL LENS (DIU150) WITH THE SAME DIOPTER SIZE (19.5D). THERE WAS INCISION ENLARGEMENT FROM 2.4 MM TO 2.8 MM, BUT NO VITRECTOMY OR SUTURES WERE REQUIRED. NO POST-OPERATIVE PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14116633 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT AFTER THE PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE, IT WAS NOTICED THERE WAS A CRACK IN THE OPTIC (MID PERIPHERAL AREA) OF THE IOL. THE IOL WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL, SAME DIOPTER) WAS IMPLANTED AS REPLACEMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. THE PATIENT WAS ONLY PRESCRIBED THE STANDARD POST-OP MEDICATIONS. THE PATIENT HAD SOME EDEMA AND SOME HEME NOTED POST-OPERATIVELY. THE HEME WAS LOCATED IN THE ANTERIOR CHAMBER. NO SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS LAST SEEN ON (B)(6) 2022, AT WHICH TIME THE EDEMA HAD RESOLVED AND THERE WAS STILL CIRCULATING HEME. THE PATIENT¿S VISUAL ACUITY WAS 20/50 AFTER ONE WEEK AND 20/30 THROUGH A PIN HOLE. THE PATIENT WILL BE SEEN AGAIN BY THE DOCTOR FOR A FOLLOW-UP. THE IOL HAS BEEN DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; Hyphema

  MAUDE report 13529231 ↗