TECNIS IOL DFW150 (REF DFW150U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474751330), received between Jan 31, 2022 and Jun 19, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 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 OPERATIVE EYE. DUE TO COMPLAINTS OF THE PATIENT NOT LIKING HER VISION, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DIU225 23.5 DIOPTER IOL. THERE WERE NO COMPLICATIONS DURING THE DURING THE LENS EXCHANGE PROCEDURE. THE SUSPECT IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 19571310 ↗
• InjuryJan 9, 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 IMPLANTED IN THE PATIENT'S RIGHT EYE (OD). IT WAS STATED THAT ABOUT THE PATIENT'S POST-OPERATION DAY 1 HER UNCORRECTED VISUAL ACUITY ( UCVA ) WAS 20/40. THE DOCTOR DID NOT TEST NEAR. THERE WAS SOME TRACE CORNEAL EDEMA, OTHERWISE GOOD. THE PATIENT PRIOR HISTORY WAS +2.25 HYPEROPE BOTH EYES (OU). ON (B)(6) 2023, IT WAS REPORTED THAT THE PATIENT WAS DOING BETTER ON POST-OPERATION DAY 6, UCVA 20/30, J3@14". THE PATIENT FELT VISION WAS IMPROVED, BUT STILL HAD A SENSE OF SOFT FOCUS. THE IOL WAS WELL-CENTERED, WITH MINIMAL CORNEAL EDEMA AND QUIET ANTERIOR CHAMBER. ON (B)(6) 2023, ABOUT A MONTH POST-IMPLANT THE DOCTOR CALCULATED MULTIPLE SCENARIOS ON BERDAHL-HARDTEN AND REPORTED THAT IT LOOKS LIKE HE NEEDS TO EXCHANGE THIS LENS WITH A DFR00V +23.0. THE LENS IS AT 80 DEG. THE DOCTOR KEPT GETTING VARIABLE POST OPERATION (POST-OP) CORNEAL CYLINDER MEASUREMENTS WITH IOL MASTER 700 VS. TOPOGRAPHER (1.18 AXIS 180 VS. 0.75 AXIS 77), BUT THERE IS NO SCENARIO IN WHICH ROTATION REDUCES CYLINDER TO LESS THAN 0.90. PRE-OP CORNEAL CYLINDER WAS ALSO VARIABLE, BUT SMALLER IN AMPLITUDE. JOHNSON AND JOHNSON WEBSITE RECOMMENDED DFR00V. THE OPTIWAVE REF

  Patient problems: Blurred Vision; Corneal Edema; Visual Disturbances; Visual Impairment

  MAUDE report 18472715 ↗
• InjuryMar 10, 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 PATIENT'S RIGHT EYE AS THE PATIENT COULD NOT TOLERATE, GET USED TO HALOS IN BOTH EYES. THE ISSUE DID NOT SIGNIFICANTLY AFFECT PATIENT¿S DAILY ACTIVITIES. ANOTHER JOHNSON & JOHNSON LENS OF DIU MODEL WAS USED AS A REPLACEMENT (THE DIOPTER WAS NOT PROVIDED). NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS INDICATED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENT¿S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Halo

  MAUDE report 16526656 ↗
• 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 GLARE, CONCENTRIC HALOS AROUND LIGHTS, AND DISTANCE VISION WAS BLURRED. THERE WAS NO CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON DCB00 LENS (DIFFERENT MODEL AND 22.5 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. PER THE CUSTOMER, THEY DID NOT SAVE THE SUSPECT PRODUCT. CONSEQUENTLY, IT WILL NOT BE RETURNED FOR EVALUATION. THE PATIENT¿S POST-OPERATIVE OUTCOME IS DESCRIBED AS HAPPY THERE IS NO GLARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 14282816 ↗
• InjuryJan 31, 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 A PATIENT'S LEFT EYE DUE TO NEGATIVE DYSPHOTOPSIA. THE PATIENT COMPLAINED OF SEEING HALOS. ANOTHER COMPETITOR LENS OF 23.5 DIOPTER WAS USED AS THE REPLACEMENT. THERE WERE NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THERE WAS NO OTHER INJURY AND THE PATIENT WAS DOING OK POST-OPERATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13391092 ↗