TECNIS IOL DFW150 (REF DFW150U140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474751149), received between Oct 27, 2021 and Nov 22, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjuryNov 22, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S EYE DUE TO GLARE AND DIFFICULTY WITH NIGHT TIME DRIVING. THE LENS WAS DECENTERED DUE TO ZONULAR WEAKNESS POST SURGICAL. THE PATIENT FEELS BETTER AFTER LENS WAS EXCHANGED (YAMANE TECHNIQUE LENS PLACEMENT USED). THERE WAS NO USE ERROR. THERE WAS NO PATIENT INJURY. THE LENS WAS OFF AXIS ONLY BY A FEW DEGREES. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 20764407 ↗
• InjuryOct 1, 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 PLACED IN THE BAG DURING A ROUTINE CATARACT PROCEDURE OF THE LEFT EYE. AFTER PLACEMENT A TEAR WAS NOTED IN THE POSTERIOR CHAMBER. THE IOL WAS REMOVED DURING THE SAME PROCEDURE, AND A VITRECTOMY WAS PERFORMED. ANOTHER JOHNSON & JOHNSON LENS, MODEL DFW150 13.5 DIOPTER WAS INSERTED IN THE SULCUS WITH NO INTERVENTIONS. NO SUTURES WERE REQUIRED AND IT'S UNKNOWN IF THE INCISION WAS ENLARGED. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND THERE WAS NO PRESCRIBED MEDICATION. REPORTEDLY, THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 15524169 ↗
• InjuryMar 8, 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 BOTHERSOME GLARE AND HALOS WHEN DRIVING AT NIGHT. IT WAS STATED THAT THE PATIENT REQUESTED THE SUSPECT IOL TO BE REMOVED. ACCOUNT INDICATED THAT THE LENS WAS REPLACED WITH A DIB00 IOL; HOWEVER, NO DIOPTER SIZE OR SERIAL NUMBER PROVIDED. THE LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13699539 ↗
• MalfunctionJan 15, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD AN ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13262412 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE) AND EXPLANTED DURING A SEPARATE SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF NOT CORRECTING PATIENT'S VISION WELL. VISUAL ACUITIES PROVIDED AS 20/60 SC (WITHOUT CORRECTION) AND 20/30 CC (WITH CORRECTION). PATIENT INDICATED THAT THEY CANNOT READ WELL AS VISION IS VERY BLURRY. THE IOL WAS REPLACED WITH A DIFFERENT MODEL LENS OF THE SAME DIOPTER SIZE. THERE WAS NO PATIENT INJURY REPORTED. THROUGH FOLLOW-UP ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME 1 DAY POST-PROCEDURE WAS REPORTED AS EXCELLENT WITH VISUAL ACUITY READINGS 20/30 SC (WITHOUT CORRECTION). NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12708548 ↗