MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS ODYSSEY TORIC II IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DRT225
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section d6a, if implanted, give date: not applicable.There is no indication the device was implanted.Section d6b, if explanted, give date: not applicable.There is no indication the device was explanted.Section h3, device evaluated by manufacturer: the device was not returned for evaluation as it was discarded.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
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.
Additional Manufacturer Narrative
Corrected data: the previously submitted follow up report mdr (follow up # 1) was inadvertently submitted with an incorrect date received by manufacturer (12/23/2025) populated in section g3.The correct date for section g3 date received by manufacturer for follow up # 1 is 12/15/2025.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
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.Section g4: pma/510(k) number: p980040.Additional information: through follow-up the customer confirmed the surgery was completed and there was no intervention like a prk (photorefractive keratectomy).No capsule tear, vitrectomy, incision enlargement, or sutures.The operative eye is the right eye.The patient is a 51-year-old male and their date of birth is on (b)(6) 1974.The doctor¿s email is (b)(6).Section a2 age or date of birth: 51 years old.Date of birth is on (b)(6) 1974.Section a3a, sex: male.Section a3b, gender: cisgender man/boy.Section e1: email address: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS ODYSSEY TORIC II IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 23699715
• Report Number: 3012236936-2025-000320
• Device Sequence Number: 9193363
• Product Code: MFK
• UDI-Device Identifier: 05050474811850
• UDI-Public: (01)05050474811850(17)280327
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRT225
• Device Catalogue Number: DRT2250155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 01/09/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/09/2026; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VISCOELASTIC.
• Patient Age: 51 YR
• Patient Sex: Male