TECNIS ODYSSEY TORIC II IOL DRT150 (REF DRT1500195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474811348), received between Aug 8, 2024 and Mar 6, 2026 — classified as 5 injuries, 5 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF A PRELOADED MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. DURING A POST-OPERATIVE EXAMINATION, THE PATIENT REPORTED EXPERIENCING UNCLEAR VISION. SUBSEQUENTLY, THE LENS WAS EXPLANTED DURING A SECONDARY SURGERY AND REPLACED WITH A NON-JOHNSON & JOHNSON TORIC LENS OF THE SAME DIOPTER (19.5D). THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS, INCLUDING UNPLANNED INCISION ENLARGEMENT, SUTURES, VITRECTOMY, OR PROCEDURAL DELAYS. THE DIRECTIONS FOR USE WAS FOLLOWED, AND NO ADDITIONAL MEDICAL ATTENTION OR MEDICATION BEYOND STANDARD CARE WAS REQUIRED. THE PATIENT HAS FULLY RECOVERED. THE PATIENT¿S PRE-OPERATIVE BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) WAS 20/25 AND BSCVA POST-OPERATIVELY 20/20 -1. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 24533732 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PRELOADED MULTIFOCAL INTRAOCULAR LENS (IOL), MODEL DRT150, IMPLANTED IN THE LEFT EYE. POSTOPERATIVELY THE PATIENT EXPERIENCED GLARE DESPITE ADAPTATION MEASURES, INCLUDING THE USE OF MIOTICS. THE SYMPTOMS REMAINED INTOLERABLE, CREATED SAFETY CONCERNS, AND PREVENTED NIGHTTIME DRIVING. AFTER A THOROUGH DISCUSSION OF RISKS, BENEFITS, AND ALTERNATIVES, THE PATIENT ELECTED TO UNDERGO AN IOL EXCHANGE. DURING A SECONDARY PROCEDURE THE ORIGINAL LENS WAS EXPLANTED AND REPLACED WITH AN IOL FROM A DIFFERENT VENDOR (NON¿JOHNSON & JOHNSON). NO UNPLANNED VITRECTOMY OR SUTURES WERE REQUIRED. THE PATIENT¿S OUTCOME WAS GOOD, WITH NO REPORTED INJURY OR COMPLICATIONS SUCH AS A CAPSULAR TEAR. NO FURTHER INFORMATION WAS PROVIDED. .

  Patient problems: Visual Disturbances

  MAUDE report 23791592 ↗
• MalfunctionAug 20, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE TECHNICIAN HAD DIFFICULTY PREPARING THE PRELOADED TORIC INTRAOCULAR LENS AS IT WAS QUITE FIRM AND RESISTED ADVANCEMENT MORE THAN USUAL. WHEN THE SURGEON FULLY ADVANCED THE LENS, IT BROKE AND WAS REPLACED DURING THE SAME PROCEDURE WITH A BACKUP LENS OF THE SAME DIOPTER. ADDITIONALLY, THERE WAS DIFFICULTY IN ADVANCING THE INJECTOR'S PLUNGER, AND THE LENS CAME OUT OF THE INSERTER BROKEN. THERE WAS NO REPORT OF UNPLANNED VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES. THE PROCEDURE WAS DELAYED BY 2 MINUTES. DIRECTIONS OF USE WERE FOLLOWED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853567 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DRT150 19.5 ODYSSEY LENS WAS EXPLANTED AND REPLACED WITH UNKNOWN IOL BECAUSE THE PATIENT EXPERIENCED VERY SEVERE GLARE AND POOR QUALITY OF VISION. THE SYMPTOMS WERE DESCRIBED AS DEBILITATING. THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY, OR NEED FOR SUTURES. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 22835917 ↗
• InjuryAug 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A TECNIS ODYSSEY TORIC INTRAOCULAR LENS (IOL) COMPLAINED OF NIGHTTIME DYSPHOTOPSIA AND POOR INTERMEDIATE VISION. THE LENS WAS SUBSEQUENTLY EXPLANTED DURING A SECONDARY SURGERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22768165 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S EYE; THE PATIENT EXPERIENCED CORNEAL EDEMA WHICH RESOLVED IN 3-4 DAYS BUT HIS EPITHELIUM WAS A BIT ROUGH 4 DAYS POST-OPERATIVE. A BANDAGE CONTACT LENS (BCL) WAS PLACED TO HELP SOOTHE THE AREA. THE DOCTOR SAID SHE HAD SEEN ANTERIOR BASEMENT MEMBRANE DYSTROPHY (ABMD) ALSO KNOWN AS MAP-DOT-FINGERPRINT DYSTROPHY IN THE PAST. HOWEVER, THE DOCTOR DID NOT SEE MUCH ABMD ON THEIR MOST RECENT PREOP VISIT. THE PATIENT¿S UNCORRECTED VISION 4 DAYS POST-OP IS 20/30 AND NEAR VISION IS J4-J5. NOT MUCH OF A REFRACTIVE ERROR. THE DOCTOR IS HOPING THAT THE PATIENT¿S READING WILL GET A BIT BETTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Abrasion; Corneal Edema; Visual Impairment

  MAUDE report 22628308 ↗
• MalfunctionJul 2, 2025Mechanical Problem; Ejection Problem; Mechanical Problem; Ejection Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS JAMMED INTO THE INSERTER BY THE INJECTOR WHICH PUSHED OFF, WENT OFF TO THE SIDE. THE INJECTOR WOULD NOT RELEASE THE LENS TO FULLY GO INTO THE PATIENT¿S RIGHT EYE CONSEQUENTLY; THE LENS WAS PARTIALLY INSERTED. THE IOL HAD TO BE REMOVED AND THE DOCTOR USED FORCEPS TO GET THE LENS OUT OF THE INCISION. A BACKUP IOL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. NO COMPLICATIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. BOTH THE BALANCED SALT SOLUTION (BSS) AND OPHTHALMIC VISCOSURGICAL DEVICE (OVD) WERE ALLOWED TO ACCLIMATIZE FULLY TO ROOM TEMPERATURE. ADDITIONALLY, AFTER THE INSERTER WAS PREPARED, THERE WERE NO DELAYS IN THE SURGERY BEFORE ADVANCING THE LENS. WHEN THE LENS WAS ADVANCED IT INITIALLY MOVED A LITTLE AND THEN GOT STUCK AND THE LENS WAS NOT POSITIONED CLOSER TO THE TIP OF THE CARTRIDGE THAN NORMAL. THE CUSTOMER REPORTED THAT THE INJECTOR IN THE CARTRIDGE TENDS TO GO OFF TO THE SIDE A LOT. USUALLY, OFF TO THE RIGHT. THE PATIENT OUTCOME WAS REPORTED AS ¿GOOD¿. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22390979 ↗
• MalfunctionNov 19, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER INSERTION OF AN INTRAOCULAR LENS (IOL) UNDER THE SCOPE THE CUSTOMER NOTICED A DIVOT IN THE IOL. THE DOCTOR REMOVED AND REPLACED IT WITH THE BACK-UP IOL. A 2.6 MM. INCISION WAS PERFORMED. THE PATIENT RECOVERED, DOING FINE, NO PATIENT INJURY. SUSPECT IOL WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 20718760 ↗
• MalfunctionAug 11, 2024Crack; Crack

  IT IS REPORTED THAT THE INTRAOCULAR LENS HAD THE INJECTOR CRACKED. IT WAS NOTED WHEN INSERTING. DURING THE SAME PROCEDURE, ANOTHER J&J LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED. THE PATIENT¿S OUTCOME IS UNKNOWN. NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19958288 ↗
• MalfunctionAug 8, 2024Crack; Crack

  IT WAS REPORTED THAT THE INTRAOCULAR LENS HAD THE INJECTOR CRACKED. IT WAS NOTED WHEN INSERTING. DURING THE SAME PROCEDURE, ANOTHER LENS WITH THE SAME MODEL AND DIOPTER WAS IMPLANTED. THE PATIENT¿S OUTCOME IS UNKNOWN. NO INJURY OR MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19943126 ↗