TECNIS ODYSSEY TORIC II IOL DRT300 (REF DRT3000235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474812604), received between Nov 25, 2025 and Mar 18, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 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 18, 2026Scratched Material

  IT WAS REPORTED THAT THE PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) EXHIBITS SIGNS OF SCRATCHING. ADDITIONAL INFORMATION NOTED DEVICE HAS BEEN OPENED AND NOT USED. IT IS UNKNOWN WHETHER THE TIP OF THE CARTRIDGE WAS DAMAGED, WHETHER ADDITIONAL RESISTANCE WAS ENCOUNTERED DURING LENS DELIVERY, OR WHETHER THE CARTRIDGE CONTACTED THE EYE. THE SPECIFIC LOCATION OF THE LENS SCRATCH COULD NOT BE CONFIRMED, AND IT IS UNKNOWN WHETHER THE OPTIC OR HAPTIC WAS DAMAGED. THE EXTENT OF PATIENT CONTACT IS ALSO UNKNOWN; HOWEVER, IT WAS NOTED THAT THE LENS WAS NOT IMPLANTED. THE PROCEDURE WAS COMPLETED USING A BACKUP LENS, (THE SERIAL NUMBER OF THE REPLACEMENT LENS IS UNKNOWN). NO PATIENT INJURY WAS REPORTED, AND NO UNPLANNED MEDICAL OR SURGICAL INTERVENTIONS, SUCH AS VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES, WERE REQUIRED. IT IS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, AND THE CURRENT PATIENT OUTCOME REMAINS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635327 ↗
• MalfunctionNov 25, 2025Crack; Mechanical Jam; Crack; Mechanical Jam

  IT WAS REPORTED THAT AN INTRAOCULAR LENS PROCEDURE WAS INTERRUPTED WHEN A PRELOADED CARTRIDGE FAILED TO ADVANCE THE LENS DURING INSERTION; THE CARTRIDGE TIP WAS DAMAGED AND CONTACTED THE PATIENT. THE LENS REMAINED STUCK IN THE CARTRIDGE. NO PATIENT INJURY OCCURRED AND NO FURTHER INTERVENTION WAS REQUIRED; THE PATIENT REMAINED WELL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648677 ↗