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

Model Number	DRT225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3, a4, a5 and a6: unknown, as information was requested but not provided.Section b3 - date of event: exact date does not apply, between implantation on the (b)(6) 2024 and the examination on the (b)(6) 2024.Section e1 - email address: unknown, as information was requested but not provided section e1 - telephone number: (b)(6).Section h3 - the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.Section h6 -health effect - clinical code: 4581: incision was enlarged an attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that about one week after the preloaded toric intraocular lens was implanted, the patient's distant visual acuity didn't improved much.The distance visual acuity was 0.6 with the naked eye and near visual acuity was 40 cm with 0.2.The patient did not present with any corneal abnormality or fundus disease.The patient is under observation, but the implantation of a lens from a different manufacturer is being considered.There were no patient injuries, and no other medical intervention was required.Through follow-up we learned, that the lens was explanted on (b)(6) 2024 and the incision was enlarged.A lens from a different manufacturer was implanted.The preoperative uncorrected visual acuity was 0.3 and the corrected visual acuity was 0.8.The postoperative uncorrected visual acuity was 0.6 and the corrected visual acuity is unknown.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: december 30, 2024.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the lens received was inspected under magnification.The lens was cleaned and presented with damage to the optic body, and cosmetic scratches.No further evaluation was performed.The complaint issues reported were not identified during product evaluation.The other observed issues during product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction identified.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.

• 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: 21044607
• Report Number: 3012236936-2024-000342
• Device Sequence Number: 8399388
• Product Code: MFK
• UDI-Device Identifier: 05050474811966
• UDI-Public: (01)05050474811966(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DRT225
• Device Catalogue Number: DRT2250210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 01/15/2025; 12/15/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 02/04/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Unknown