TECNIS IOL DFW300 (REF DFW300U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474752399), received between Oct 1, 2021 and May 6, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A MODEL DFW300 INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS), AND A MODEL DFW375 IOL IN THE RIGHT EYE (OD) IN (B)(6) 2021. IN (B)(6) 2022 THE PATIENT COMPLAINED OF EXCESSIVE DYSPHOTOPSIA IN BOTH EYES, AFFECTING THEIR ABILITY TO PERFORM ACTIVITIES THEY PREVIOUSLY CONDUCTED. A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE WAS PERFORMED ON BOTH EYES IN (B)(6) 2022. THE PATIENT CONTINUED TO BE UNHAPPY AFTER THE YAG PROCEDURE. PATIENT¿S CURRENT VISION IS REPORTED AS 20/25 DISTANCE, 20/100 INTERMEDIATE, AND 20/25 NEAR. THERE HAS BEEN NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED AT THIS TIME, AND THERE ARE NO REPORTED PRE-EXISTING MEDICAL CONDITIONS. PRODUCT IS NOT AVAILABLE FOR EVALUATION AS THE IOLS REMAIN IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS TO CAPTURE THE EVENT FOR THE LEFT EYE (OS). A SEPARATE REPORT IS BEING SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Discomfort; Visual Disturbances

  MAUDE report 14312556 ↗
• InjuryJan 11, 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 PATIENT'S LEFT EYE DUE TO PATIENT UNHAPPY WITH THEIR DISTANCE VISION. THIS WAS REPLACED WITH A NON JOHNSON AND JOHNSON IOL, 17.0 DIOPTER AND THE PATIENT IS WELL POST-OP. NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Discomfort; Halo

  MAUDE report 13233115 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE IOL WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO 2/2 CLOUD OVER VISION, DULL COLORS, DIFFICULTY WITH NEAR AND INTERMEDIATE VISION. THE CUSTOMER REPORTED THE PATIENT¿S VISION AS POST-OPERATION (PO) M.R: +.75-.75 X 178 SE:+.37. THEIR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) AT ONE MONTH PO 20/30+, UNCORRECTED NEAR VISUAL ACUITY (UCNVA) J2. THERE WAS NO VITRECTOMY REQUIRED AND THE INCISION WAS NOT ENLARGED. THE REPLACEMENT LENS IS MODEL ZCU300 DIOPTER 18.0. REPORTEDLY, THE PATIENT IS DOING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12564983 ↗