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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted due to patient had dysphotopsias that were not more extreme than normal.It was stated that product will not be returned.No other information was provided.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that "section g4 - combination product" field inadvertently was left blank and not populated in the initial mdr report.In review, it was also noticed that " section h2 - if follow-up, what type" box of "additional information" was inadvertently not checked in follow up mdr report #1.The information has been corrected in this supplemental mdr report as indicated below: section g4: combination product: no.Section h2 - if follow-up: additional information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: 2/28/2024 the completed complaint intake form was received which contains new information and supplemental mdr is required.The issue reported was positive dysphotopsia.The replacement lens was a tecnis toric lens, model diu 21.0 diopter power.The patient's daily activities were affected prior to explant surgery as the patient was unable to drive.Patient outcome: temporarily impaired.There were no unplanned incision enlargement, no unplanned vitrectomy and no unplanned sutures and no delay in procedure.Fields below updated: section a2: patient's age/ date of birth: 60 yrs.Old./ (b)(6) 1961.Section a3: patient's gender: female.Section b3: date the event: (b)(6) 2021.Section d6a:date of implant: (b)(6) 2021.Section d6b: date of explant: (b)(6) 2022.Section e1: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15407607
• Report Number: 3012236936-2022-02275
• Device Sequence Number: 6744623
• Product Code: MFK
• UDI-Device Identifier: 05050474751286
• UDI-Public: (01)05050474751286(17)240609
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/20/2024

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: 06/09/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U210
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 02/27/2024; 03/19/2024
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 03/19/2024; 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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: 60 YR
• Patient Sex: Female