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 Impairment (2138)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's left eye because they experienced a hyperopic outcome.The replacement lens information was not provided.There was no vitrectomy, sutures, or incision enlargement required.There was no patient injury.No further information was provided.
Additional Manufacturer Narrative
Date of event: the exact date is unknown/not provided.Best estimate is between (b)(6) 2022 to (b)(6) 2022.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 missing information; however, there is no additional information available.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
The replacement lens information is now provided as (b)(6).
Additional Manufacturer Narrative
Received additional information from the customer that the explant date initially reported was (b)(6) 2022.The customer has now indicated the correct explant date as (b)(6) 2022.Also, provided was the age of the patient to be 74 yrs.Old.Moreover, the replacement lens was for serial number (b)(6).The originally implanted lens is the same model diopter 22.0.Per explant guidance, the event is not due to a product quality issue with the original lens.Therefore, considering the reported issue of hyperopic outcome and the replacement lens information, the event is re-assessed as not reportable.Field below is updated to reflect correction and additional information.There will no longer be any further reporting under mfr report number 3012236936-2022-01071.Section a2: age: 74 yrs.Old.Section d6b if explanted; give date: (b)(6) 2022.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: 14283772
• Report Number: 3012236936-2022-01071
• Device Sequence Number: 6256269
• Product Code: MFK
• UDI-Device Identifier: 05050474751309
• UDI-Public: (01)05050474751309(17)240711
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 07/21/2022

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: 07/11/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U220
• 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: 04/19/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2021
• 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: 74 YR
• Patient Sex: Female