TECNIS IOL DFW375 (REF DFW375U055)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474752740), received between Feb 24, 2022 and Mar 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT AS AN INTRAOCULAR LENS (IOL) WAS BEING INSERTED IN A PATIENT'S RIGHT EYE, IT WAS NOTICED THAT THE IOL WAS SCRATCHED. BOTH THE ORIGINAL AND BACK UP LENS HAD SCRATCHED LENSES. THE FIRST LENS WAS REMOVED FROM THE EYE AND A REPLACEMENT LENS OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. IT APPEARS THAT THE CARTRIDGE TIP WAS BENT/ GIVING SOME RESISTANCE WHEN TWISTING OUT. THE SECOND IOL REMAINS IMPLANTED IN PATIENT'S EYE AS SCRATCH IS ON THE OUTER PERIMETER. NO VITRECTOMY AND NO SUTURES, BUT SLIGHTLY ENLARGE THE WOUND TO 2.7MM FROM 2.4MM. POST OP WEEK-1 THE PATIENT IS DOING WELL WITH NO VISUAL DAMAGE OR CHANGES, HE DOES NOT SEE THE CRACK AS IT IS OUT OF HIS PRIMARY VISUAL AXIS. HE IS 20/25 AND J1. THERE WAS NO PATIENT INJURY REPORTED. THE SURGEON IS PLANNING TO SEE HOW PATIENT DOES AND IF THERE ARE VISUAL ISSUES (SHADOWS), WILL THEN DECIDE TO EXCHANGE THE LENS. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE ORIGINAL LENS THAT WAS IMPLANTED AND REMOVED. A SEPARATE REPORT WILL BE SUBMITTED ON THE EVENT REPORTED WITH THE SECOND (REPLACEMENT) LENS IMPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13796134 ↗
• MalfunctionFeb 24, 2022Crack; Scratched Material; Crack; Scratched Material

  IT WAS REPORTED THAT A DOCTOR WAS IMPLANTING AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE, AND THE IOL WAS SCRATCHED. IT APPEARS THAT THE CARTRIDGE TIP WAS BENT/ GIVING SOME RESISTANCE WHEN TWISTING OUT. NEVERTHELESS, THE SUSPECT IOL WAS IMPLANTED IN PATIENT'S EYE AS SCRATCH IS ON THE OUTER PERIMETER. SURGEON IS PLANNING TO SEE HOW PATIENT DOES, IF HE CAN SEE AND WILL THEN DECIDE IF THE SURGEON WILL EXPLANT IT. NO VITRECTOMY AND NO SUTURES, BUT SLIGHTLY ENLARGE THE WOUND TO 2.7MM FROM 2.4MM. POST OP WEEK 1 HE IS DOING WELL, HE DOESN'T SEE THE CRACK AS IT IS OUT OF HIS PRIMARY VISUAL AXIS. HE IS 20/25 AND J1. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13595907 ↗