TECNIS IOL DFW150 (REF DFW150U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474751309), received between Jan 20, 2022 and Jun 3, 2025 — 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.

• InjuryJun 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AN INTRAOCULAR LENS EXPLANT WITH UNPLANNED SUTURES, DURING WHICH A SYNERGY LENS WAS REMOVED AND REPLACED WITH A SYMFONY LENS. THE PATIENT HAD NOTED ISSUES WITH DIFFICULTY SEEING STREET SIGNS AND EXPERIENCING GLARE. THE PATIENT'S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BCVA) WAS DOCUMENTED AS 20/20. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22137137 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS HAD EXPLANTED FOR AN UNKNOWN REASON. THE LENS WAS REMOVED AND REPLACED IN A SECONDARY SURGICAL PROCEDURE WITH ANOTHER J&J MONOFOCAL IOL. THE ACCOUNT WON¿T BE RETURNING THE LENS BUT THEY WOULD LIKE THE CREDIT FOR THE EXPLANTED ONE. IT IS UNKNOWN IF THERE WAS INJURY AND SURGICAL AND MEDICAL INTERVENTIONS ARE REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 19233191 ↗
• InjuryDec 6, 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 PATIENTS LEFT EYE AS THE PATIENT HAS BEEN UNHAPPY SINCE THE IMPLANT SURGERY. THERE WAS NO SIGN OF RESIDUAL REFRACTIVE ERROR. THE PATIENT REPORTS BLURRED VISION, ISSUES WITH DEPTH PERCEPTION, DIFFICULTY SEEING STREET SIGNS AND HALOS. THE IOL HAS BEEN DISCARDED AND NOT AVAILABLE FOR RETURN. ANOTHER JOHNSON & JOHNSON LENS, MODEL ZKB00 22.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO UNPLANNED PROCEDURES SUCH AS SUTURES OR VITRECTOMY WERE PERFORMED. THE PATIENT DID GREAT DURING THE PROCEDURE AND WAS DISCHARGED IN GOOD DISPOSITION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15928376 ↗
• InjuryJul 21, 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 DISSATISFIED PATIENT AND RESIDUAL REFRACTIVE ERROR THAT IS UNACCEPTABLE. IT WAS STATED THAT DOCTOR USED LENSTAR BIOMETER AND THE QUANTAL ASCAN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15076108 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD BILATERAL INTRAOCULAR LENS (IOL) IMPLANTS. BUT THE RIGHT EYE LENS IS PLANNED TO BE REMOVED ON (B)(6) 2022 DUE TO GLARE, BLURRY (CLOUDY) VISION AND LIGHT SENSITIVITY WITH LOSS OF 2 OR MORE LINES OF BSCVA (BEST SPECTACLE CORRECTED VISUAL ACUITY). IT WAS INDICATED THAT BOTH EYES ARE IMPACTED AND THAT THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH PATIENT'S DAILY ACTIVITY. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REPORTED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 14810714 ↗
• InjuryMay 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) FROM THE PATIENT'S LEFT EYE WAS EXPLANTED DUE TO PATIENT "CANNOT SEE ANYTHING AT DISTANCE. CANNOT SEE TO DRIVE." VISUAL ACUITY IS 20/30 RIGHT EYE (OD), 20/25 LEFT EYE (OS) BUT IT IS NOT FUNCTIONAL. IT WAS PROVIDED THAT THE PATIENT IS EXCEEDINGLY UNHAPPY. THE SUSPECT IOL WAS REPLACED WITH A ZCU150 MODEL LENS, 22.5 DIOPTER POWER. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED POST-EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14459604 ↗
• InjuryMay 4, 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 LEFT EYE BECAUSE THEY EXPERIENCED A HYPEROPIC OUTCOME. THE REPLACEMENT LENS INFORMATION WAS NOT PROVIDED. THERE WAS NO VITRECTOMY, SUTURES, OR INCISION ENLARGEMENT REQUIRED. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 14283772 ↗
• InjuryMay 4, 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 IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT 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 PRIOR TO THE YAG PROCEDURE, GLARE WAS 360 DEGREES AND AFTER YAG PROCEDURE GLARE ~ 5 O'CLOCK TO 1 O'CLOCK POSITION. 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 C

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

  MAUDE report 14275039 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A SYNERGY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE BECAUSE THE PATIENT REPORTED OF SEEING HALOS DURING A POST-OPERATIVE EXAM. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE SECONDARY PROCEDURE. ANOTHER JOHNSON & JOHNSON ZCT150 LENS (DIFFERENT MODEL AND SAME DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. REPORTEDLY, THE PATIENT IS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 13578970 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYNERGY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL COMPLICATION. THE PATIENT WAS UNABLE TO TOLERATE THE MULTIFOCAL LENS. THE REPLACEMENT LENS IS A MODEL DIU250, 22.0 DIOPTER. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE SECONDARY PROCEDURE. REPORTEDLY, THE PATIENT POST-OP STILL WITH MILD CORNEAL EDEMA, BUT HEALING WELL. THE CUSTOMER INDICATED THE EXPLANTED LENS WAS DISCARDED AND NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Corneal Edema; Visual Disturbances

  MAUDE report 13312132 ↗