TECNIS ODYSSEY TORIC II IOL
Report
- Report Number
- 3012236936-2025-000309
- Event Type
- Injury
- Date Received
- November 25, 2025
- Date of Event
- October 26, 2025
- Report Date
- January 28, 2026
- Manufacturer
- AMO MANUFACTURING NETHERLANDS
- Product Code
- MFK
- UDI-DI
- 05050474811362
- PMA / PMN Number
- P980040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTED DATA: UPON FURTHER REVIEW IT WAS NOTED THAT SECTION G4: PMA/510(K) NUMBER IN THE INITIAL MDR WAS INADVERTENTLY SUBMITTED MISSING THE ¿P¿ BEFORE THE NUMERICAL VALUE. THE COMPLETE NUMBER IS P980040. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
ADDITIONAL INFORMATION: SECTION D-9: DEVICE AVAILABLE FOR EVALUATION: YES. SECTION D-9: DEVICE DATE RETURNED TO MANUFACTURER: 06-JAN-2026. SECTION H-3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: THE LENS WAS RECEIVED INSIDE A NON-JOHNSON & JOHNSON POUCH. DURING A VISUAL INSPECTION, THE DEVICE WAS INSPECTED UNDER MAGNIFICATION. THE LENS WAS COATED IN VISCOELASTIC RESIDUE. THE LENS WAS CLEANED AND INSPECTED, AND NO ISSUES THAT COULD CONTRIBUTE TO THE COMPLAINT ISSUES WERE OBSERVED. DURING THE PRODUCT EVALUATION IT WAS CONFIRMED THAT THE PHYSICAL CHARACTERISTICS OF THE LENS MATCHED A DRT150 MODEL LENS. NO OTHER ISSUES WERE IDENTIFIED. THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED; THE UNITS WERE RELEASED IN ACCORDANCE WITH SPECIFICATIONS. THE LENS DIOPTER RESULTS OBTAINED FROM THE MIQ ELECTRONIC SYSTEM SHOW THAT THIS PRODUCTION ORDER WAS RELEASED WITHIN DIOPTER SPECIFICATIONS. A SEARCH REVEALED THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PRODUCTION ORDER. CONCLUSION: BASED ON THE COMPLAINT INVESTIGATION RESULTS, THE PRODUCT WAS RELEASED WITHIN SPECIFICATIONS. NO PRODUCT DEFICIENCY OR PRODUCT MALFUNCTION WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
ADDITIONAL INFORMATION: SECTION A-3B PATIENT GENDER: MALE. SECTION H-3 DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
THE DRT150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). DUE TO COMPLAINTS OF BLURRED VISION, GLARE AT BOTH DISTANCES AND READING, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRN00V 21.5 IOL. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/40 AND POST-OPERATIVE WAS 20/30. THE PATIENT¿S DAILY ACTIVITIES WERE NOT SIGNIFICANTLY AFFECTED. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE EXPLANT PROCEDURE. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. PATIENT PROGNOSIS POST LENS EXCHANGE WAS REPORTED AS FULLY RECOVERED AND BCVA POST-OPERATIVE WAS 20/20-2. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2467901 | TECNIS ODYSSEY TORIC II IOL | LENS, MULTIFOCAL INTRAOCULAR | MFK | AMO MANUFACTURING NETHERLANDS | DRT150 | 05050474811362 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Required Intervention |