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	Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the dfw150 model intraocular lens (iol) was implanted into the patient¿s operative eye.Due to complaints of the patient not liking her vision, the iol was explanted in a secondary surgical procedure and replaced with a diu225 23.5 diopter iol.There were no complications during the during the lens exchange procedure.The suspect iol is not available for return as it was discarded.No further information is available.
Additional Manufacturer Narrative
Additional information: section a-2 patient age/date of birth: unknown/asked information unavailable.Section a-3a patient sex: unknown/asked information unavailable.Section a-3b patient gender: unknown/asked information unavailable.Section a-4 patient weight: unknown/asked information unavailable.Section a-5 patient ethnicity: unknown/asked information unavailable.Section a-6 patient race: unknown/asked information unavailable.Section b-3: date of event: unknown/asked information unavailable.The best estimation date is between (b)(6) 2023 and (b)(6) 2024 (iol implant and explant dates).Section h-3 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, 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 report will be filed.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.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: 19571310
• Report Number: 3012236936-2024-000172
• Device Sequence Number: 8470385
• Product Code: MFK
• UDI-Device Identifier: 05050474751330
• UDI-Public: (01)05050474751330(17)240924
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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: 09/24/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U235
• 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: 06/07/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2021
• 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 Sex: Unknown