TECNIS IOL DFW150 (REF DFW150U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474751286), received between Jan 5, 2022 and Sep 4, 2025 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DFW150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. DUE TO COMPLAINTS OF THE IOL NOT WORKING AS INTENDED, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE; INFORMATION REGARDING THE REPLACEMENT IOL IS UNAVAILABLE. PATIENT PROGNOSIS POST LENS EXCHANGE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 22974408 ↗
• InjuryJun 28, 2023Adverse 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 THE RIGHT EYE DUE TO BLURRED VISION. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT. THERE WAS NO PATIENT INJURY. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS DOING WELL POST-OPERATIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 17221608 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW150 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF DISTANCE VISION (DV) NOT CRISP IN BOTH EYES (OCULUS UTERQUE - OU), UNABLE TO FOLLOW GOLF-BALL, AND REPLACED WITH A ZCT150 20.5 DIOPTER IOL. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY: 20/40-2. THERE WAS NO SUTURE(S) AND NO VITRECTOMY HOWEVER THE INCISION WAS ENLARGED. NO MEDICAL ATTENTION WAS REQUIRED AND NO MEDICATION WAS PRESCRIBED. PATIENT OUTCOME POST-LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED. POST-OPERATIVE BEST CORRECTED VISUAL ACUITY AND UCDV POS: 20/25+2. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 16659667 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HALOS AT NIGHT, BLURRY VISION, AND GLARE IN THEIR LEFT EYE (OS) RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY WAS 20/60 WITH GLASSES AND POST OPERATIVE VISUAL ACUITY WAS 20/70 WITHOUT CORRECTION. NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED AND THERE WAS NO PATIENT INJURY. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT. THE PATIENT IS STATED TO BE HAPPY WITH THE EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15636447 ↗
• InjurySep 12, 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 PATIENT HAD DYSPHOTOPSIAS THAT WERE NOT MORE EXTREME THAN NORMAL. IT WAS STATED THAT PRODUCT WILL NOT BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 15407607 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTH CARE PROVIDER REPORTED THEY EXPLANTED THE INTRAOCULAR LENS (IOL) FROM THE PATIENT'S LEFT EYE BECAUSE THEY WERE EXPERIENCING HALOS AROUND LIGHT, GLARE, AND SUBJECTIVE VISUAL DISTURBANCES. THEY REPORTED EYES BEING TIRED, HURT, ACHY, AND PAINFUL. PATIENT IS VERY SENSITIVE TO LIGHT. THEIR DISTANCE AND NEAR VISION IS BLURRY. THE ISSUES WERE OBSERVED DURING A POST-OP EXAM. THE EXPLANTED IOL WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. THE PATIENT¿S CURRENT STATUS IS UNKNOWN. THIS PATIENT HAD BILATERAL EXPLANTS. NO FURTHER INFORMATION WAS REPORTED. THIS REPORT CAPTURES INFORMATION FOR THE PATIENT'S LEFT EYE. AND A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT'S RIGHT EYE.

  Patient problems: Blurred Vision; Eye Pain; Halo; Visual Disturbances

  MAUDE report 14640393 ↗
• InjuryJan 31, 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 UNACCEPTABLE VISION DUE TO POWER. PRE-OP VISUAL ACUITY (VA), DISTANCE VISUAL ACUITY (DSC) 20/25, BRIGHTNESS ACUITY TEST (BAT) 20/50, POST-OP VA DSC 20/25. THE EXPLANTED IOL WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL, WITH THE SAME DIOPTER POWER. THERE WAS NO DELAY IN PROCEDURE REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13406806 ↗
• InjuryJan 31, 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 PATIENT WAS NOT HAPPY WITH HER VISION. THE PATIENT COMPLAINED OF DISTANCE BLURRY, BLIND WHITE SPOT WHILE READING, AND VISUAL ACUITY (VA) FLUCTUATES, BUT MOSTLY FUZZY ALL THE TIME. AT 3-WEEKS POST-OPERATIVE (OP), PATIENT SAYS EYE STILL FEELS SWOLLEN AND UNCOMFORTABLE WITH MORE DISTANCE BLUR THAN NEAR BLUR. THEREFORE, THE LENS WAS EXCHANGED FOR ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL AND LOWER DIOPTER) AS A REPLACEMENT LENS. THE INCISION WAS ENLARGED, HOWEVER, NO VITRECTOMY OR SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT IS DOING GREAT POST-EXPLANT. NO ADDITIONAL INFORMATION WAS PROVIDED. VISUAL ACUITY PRE-OPERATIVE: 20/40. VISUAL ACUITY POST-OPERATIVE: 20/20.

  Patient problems: Blurred Vision; Eye Pain; Inflammation; Visual Disturbances

  MAUDE report 13391043 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT BELIEVED SHE WAS GOING TO HAVE 20/20 VISION AFTER HAVING THE SURGERY AND NOT HAVE TO USE GLASSES HOWEVER, PATIENT CANNOT SEE FAR AWAY. SINCE THE SURGERY, THE PATIENT¿S VISION HAS NOT GETTING BETTER. DURING A POST-OP APPOINTMENT, THE PATIENT WAS TOLD BY HER DOCTOR THAT SINCE SHE (THE PATIENT) HAD LASIK SURGERY 6-7 YEARS AGO, THAT THE CATARACT SURGERY RESULTS MAY NOT BE AS GOOD. PATIENT IS NOT HAPPY SHE PAID A LOT TO HAVE THIS MODEL IOL IMPLANTED & WILL TALK WITH HER DOCTOR ABOUT THIS. PATIENT HAS AN APPOINTMENT FOR A SECOND OPINION FROM A DIFFERENT DOCTOR. THE LENS IS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. ADDITIONAL WAS INFORMATION WAS RECEIVED STATING THE IOL WAS EXPLANTED DUE TO VISUAL COMPLAINTS OF DISTANCE AND HALO/GLARE. ANOTHER JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT (DIFFERENT MODEL IOL WITH A DIFFERENT DIOPTER SIZE, DIB00 20.0 DIOPTER). A 2.7MM MICROKERATOME BLADE WAS USED TO MAKE TEMPORAL MAIN INCISION FOR EXPLANT. THE ORIGINAL INCISION WAS 2.4MM. NO SUTURES WERE USED AND NO VITRECTOMY WAS PERFORMED. THERE WAS NO PATIENT POST-EXPLANT INJURY.

  Patient problems: Blurred Vision; Discomfort; Halo; Visual Disturbances

  MAUDE report 13166197 ↗