TECNIS IOL DFW300 (REF DFW300U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474752405), received between Oct 29, 2021 and Aug 20, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC II INTRAOCULAR LENS (IOL) WAS IMPLANTED IN A PATIENT'S RIGHT EYE, AND THEY ARE HAVING INTOLERABLE GLARE AND HALO A MONTH POST OP. THE DOCTOR IS PLANNING TO DO AN IOL EXCHANGE AND CHANGE HER TO A MONOVISION TORIC, TO USE THE TECNIS TORIC. IT WAS NOTED THAT THE SUSPECT IOL WAS EXPLANTED ON (B)(6) 2024. THIS WAS REPLACED WITH A DIU300, SAME DIOPTER POWER SIZE AS ORIGINAL IOL. THE DOCTOR DID ENLARGE THE INCISION TO ABOUT 4 MM TO REMOVE THE OLD LENS. THERE WAS NO VITRECTOMY NEEDED. THE DOCTOR ALSO DID PLACE 2 SUTURES IN THE MAIN INCISION JUST AS A SAFETY PRECAUTION SINCE HE HAD ENLARGED IT. THE DOCTOR THOUGHT THAT IT IS TOO EARLY TO TELL IF THE REPLACEMENT HELPED THE VISION ISSUES BECAUSE SHE HAS SOME CORNEAL EDEMA AND HER PUPIL IS STILL DILATED FROM SURGERY YESTERDAY, SO HER VISION WAS VERY BLURRY TODAY ((B)(6) 2024), AT ABOUT 20/50. WHEN THE DOCTOR WAS ASKED IF THE HALOS/GLARE WERE GONE, SHE HAD A HARD TIME ANSWERING, LIKELY BECAUSE OF THE PERSISTENT DILATION. THE PATIENT IS DOING JUST FINE, HER INTRAOCULAR PRESSURE (IOP) IS A LITTLE HIGH, LIKELY SOME RETAINED VISCOELASTIC, SO SHE HAS A LITTLE BIT OF A HEADACHE, BUT THAT IS IMPROVING. ADDITIONAL INFORMATIO

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20002470 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SYNERGY INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT COULD NOT TOLERATE THE HALOS, AND HE NEEDED A TORIC 19.5 D DIU300 LENS. ADDITIONAL INFORMATION STATED THAT THE TECNIS SYNERGY TORIC SIMPLICITY LENS WAS IMPLANTED IN PATIENTS LEFT EYE. THE LENS WAS EXPLANTED DUE TO PERSISTENT GLARE. FIRST ONSET OF SYMPTOMS WAS WITHIN A FEW DAYS OF SURGERY. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. THERE WAS NO OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT WAS DOING GREAT. GLARE GONE 1 DAY STATUS POST THE EXCHANGE. THE PRODUCT IS NOT BEING RETURNED. UPON FURTHER FOLLOW UP, IT WAS CONFIRMED THAT THE LENS WAS EXPLANTED DUE TO BOTH HALOS AND GLARE AND THE IOL WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17372162 ↗
• MalfunctionOct 29, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS DEFECTIVE AS THERE SEEMED TO BE A SCRATCH LOCATED IN THE MIDDLE OF THE LENS. THE LENS WAS NOT USED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT CONTACT. THE LENS IS NOT BEING RETURNED AS IT WAS NOT SAVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720632 ↗