TECNIS IOL DFW225 (REF DFW225U160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751774), received between Oct 28, 2021 and Jan 4, 2023 — classified as 2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) HAD A LENS DEFECT. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16098550 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD UNCOMPLICATED CATARACT SURGERY IN HIS RIGHT (OD) EYE. AT 1 DAY POST-OP AFTER THE IMPLANTATION OF A TECNIS SYNERGY INTRAOCULAR LENS (IOL), THE PATIENT COMPLAINS OF HAVING BLURRY VISION. THE PATIENT STATES HE CANNOT SEE DISTANCE OR NEAR ON (B)(6) 2021. HE ALSO SEES CIRCLES AROUND LIGHTS AND DOUBLE IMAGES. THE PATIENT'S VISUAL ACUITY (VA) IS STILL POOR NOT CORRECTING BETTER THAN 20/40. THE OUTCOME SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF HIS DAILY LIFE. THE SURGEON FOLLOWED PATIENT CLOSELY FROM (B)(6) 2021 TO (B)(6) 2021. SUBSEQUENTLY, THE SURGEON EXPLANTED THE LENS AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS. REPORTEDLY, THE LENS WAS DISCARDED AND PATIENT CURRENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 13492577 ↗
• InjuryOct 28, 2021Adverse 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 DUE TO REFRACTIVE ERROR AND AS THE PATIENT WAS INTOLERANT TO MULTIFOCAL IOL. A REPLACEMENT LENS MODEL ZCB00, 21.0 DIOPTER WAS USED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES DONE. NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Visual Impairment

  MAUDE report 12716724 ↗