TECNIS ODYSSEY TORIC II IOL DRT225 (REF DRT2250155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474811850), received between Dec 2, 2025 and Dec 2, 2025 — classified as 3 malfunctions.

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

• MalfunctionDec 2, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THREE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENSES (IOL) HAD CRACKS OR SHARDS INSIDE THE INTACT LENS. ALL WERE DIFFICULT TO TURN AND FELT STUCK DURING THE PROCEDURE. OF THE THREE LENSES, TWO HAD PATIENT CONTACT AND ONE DID NOT, ALTHOUGH IT IS UNCLEAR WHICH SPECIFIC LENS DID NOT HAVE CONTACT. THE EXTENT OF CONTACT WAS ALSO NOT PROVIDED. THE CUSTOMER CONFIRMED THAT VISCOELASTIC WAS USED AND THE DEVICES WERE PREPARED IN THE USUAL MANNER. THE LENS EVENTUALLY IMPLANTED WAS OF THE SAME MODEL AND DIOPTER AS THE AFFECTED LENSES. NO PATIENT INJURY OCCURRED, AND NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT¿S OUTCOME WAS REPORTED AS FINE, AND THE PATIENT IS HAPPY AND HEALTHY. NO FURTHER INFORMATION IS AVAILABLE. NOTE. THREE SEPARATE REPORTS ARE BEING SUBMITTED. MANUFACTURER REPORT NUMBER 3012236936-2025-0003203. MANUFACTURER REPORT NUMBER 3012236936-2025-0003204.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699765 ↗
• MalfunctionDec 2, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THREE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENSES (IOL) HAD CRACKS OR SHARDS INSIDE THE INTACT LENS. ALL WERE DIFFICULT TO TURN AND FELT STUCK DURING THE PROCEDURE. OF THE THREE LENSES, TWO HAD PATIENT CONTACT AND ONE DID NOT, ALTHOUGH IT IS UNCLEAR WHICH SPECIFIC LENS DID NOT HAVE CONTACT. THE EXTENT OF CONTACT WAS ALSO NOT PROVIDED. THE CUSTOMER CONFIRMED THAT VISCOELASTIC WAS USED AND THE DEVICES WERE PREPARED IN THE USUAL MANNER. THE LENS EVENTUALLY IMPLANTED WAS OF THE SAME MODEL AND DIOPTER AS THE AFFECTED LENSES. NO PATIENT INJURY OCCURRED, AND NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT¿S OUTCOME WAS REPORTED AS FINE, AND THE PATIENT IS HAPPY AND HEALTHY. NO FURTHER INFORMATION IS AVAILABLE. NOTE. THREE SEPARATE REPORTS ARE BEING SUBMITTED. MANUFACTURER REPORT NUMBER: 3012236936-2025-0003202. MANUFACTURER REPORT NUMBER: 3012236936-2025-0003204.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699715 ↗
• MalfunctionDec 2, 2025Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT THREE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENSES (IOL) HAD CRACKS OR SHARDS INSIDE THE INTACT LENS. ALL WERE DIFFICULT TO TURN AND FELT STUCK DURING THE PROCEDURE. OF THE THREE LENSES, TWO HAD PATIENT CONTACT AND ONE DID NOT, ALTHOUGH IT IS UNCLEAR WHICH SPECIFIC LENS DID NOT HAVE CONTACT. THE EXTENT OF CONTACT WAS ALSO NOT PROVIDED. THE CUSTOMER CONFIRMED THAT VISCOELASTIC WAS USED AND THE DEVICES WERE PREPARED IN THE USUAL MANNER. THE LENS EVENTUALLY IMPLANTED WAS OF THE SAME MODEL AND DIOPTER AS THE AFFECTED LENSES. NO PATIENT INJURY OCCURRED, AND NO SURGICAL OR MEDICAL INTERVENTIONS WERE REQUIRED. THE PATIENT¿S OUTCOME WAS REPORTED AS FINE, AND THE PATIENT IS HAPPY AND HEALTHY. NO FURTHER INFORMATION IS AVAILABLE. NOTE. THREE SEPARATE REPORTS ARE BEING SUBMITTED. NOTE. THREE SEPARATE REPORTS ARE BEING SUBMITTED. MANUFACTURER REPORT NUMBER 3012236936-2025-0003202. MANUFACTURER REPORT NUMBER 3012236936-2025-0003203. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699695 ↗