MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a few months after the preloaded multifocal intraocular lens (iol) was implanted in the patient's operative eye, the patient experienced dysphotopsia and halos and could not adjust.The patient will have the lens removed.The iol remains implanted.No further information was provided.Further information was provided that the iol was explanted and another johnson & johnson lens, model zcb00 was implanted as a replacement.The lens that was removed was not saved by the operating room (or).No other information is available.
Additional Manufacturer Narrative
Section a2, a3b, a4, a5, a6: unknown/ not provided.Section b3: date of event: exact date unknown/not provided.Best estimate date is between nov.2, 2023- mar 21, 2024.Section h3: 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, 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 missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information was received that the patient's race is white.The patient did not have any complications after the explant and is doing fine.No further information was provided.The following field has been updated accordingly: section a6: race: white.Correction: in review, it was noticed that the date (b)(6) 2024) was inadvertently entered in the section "g3 - date received by manufacturer" of the initial mdr report, which is incorrect.The correct date received by manufacturer that should have been entered is "mar 27, 2024"; therefore, the information has been corrected in this supplemental mdr report as indicated below: section g3 - date received by manufacturer: mar 27, 2024.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• 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: 19235674
• Report Number: 3012236936-2024-000128
• Device Sequence Number: 7952666
• Product Code: POE
• UDI-Device Identifier: 05050474761810
• UDI-Public: (01)05050474761810(17)250411
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/16/2024

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: 04/11/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU210
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2022
• 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 Sex: Male
• Patient Race: White