MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3a, a3b, a4, a5 and a6: unknown, information was requested but not provided.Section b3: date of event: unknown /not provided.The best estimate date is between nov 14, 2023 and feb 26, 2025.Section d6b: if explanted, give date: unknown/ information not provided.Section h3(no): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain additional information regarding the event; however, to date, the information 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 a monofocal toric intraocular lens (iol) was explanted from a patient's left eye.The reason for the explant was not specified.No further information was provided.
Additional Manufacturer Narrative
Additional information.Customer provided additional information.Therefore, the following sections are being updated accordingly: section b5 - describe event or problem: the reason for the explant was due to lens shifted superiorly.The lens was not sitting center, patient was unable to get optimal vision.A sulcus lens was used for the replacement lens.Patient was referred to a retina specialist for additional surgeries.There was no patient injury reported.The device is not returning.Section a3a - sex: male.Section a5 - ethnicity: not hispanic/latino.Section a6 - race: white.Section b3.Date of event: nov 15, 2023.Section d6b.If explanted, give date: (b)(6) 2024.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 21634869
• Report Number: 3012236936-2025-000077
• Device Sequence Number: 12634876
• Product Code: MJP
• UDI-Device Identifier: 05050474747647
• UDI-Public: (01)05050474747647(17)260209
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 04/28/2025

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 Expiration Date: 02/09/2026
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U160
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White