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)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a tecnis eyhance intraocular lens (iol) explanted from the patient's right (od) eye due to mechanical complications.The patient did not see as clearly as they would like to.The replacement lens is the same model but a higher diopter (22.0).There was no vitrectomy, incision enlargement, or sutures required.Reportedly the patient is doing good post exchange.The lens was been discarded.No further information was provided.
Additional Manufacturer Narrative
Date of event: unknown as information was not provided.The best estimate would be between 1/11/2022 and 1/25/2022.The device was not returned for analysis 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected info: additional information was received on 2/9/2022 that the lens model/serial number initially provided was incorrect.The correct lens model/serial number is a dfw150, serial number (b)(6) 21.5 diopter.The following sections have been updated accordingly: section d2 common device name: lens, multifocal intraocular.Section d-2 device product code: mfk.Section d-4 model number: dfw150.Section d-4 catalog number: dfw150u215.Section d-4 device serial number: (b)(6).Section d-4 expiration date: 4/20/2024.Section d-4 udi number: (b)(4).Section h-4 device manufacture date: 4/20/2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected info: upon further review it was discovered that replacement lens is a diu150, 22.0 diopter.Therefore, it has been corrected in this supplemental report.All pertinent information available to johnson and 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: 13462562
• Report Number: 3012236936-2022-00306
• Device Sequence Number: 5075719
• Product Code: MFK
• UDI-Device Identifier: 05050474746534
• UDI-Public: (01)05050474746534(17)240115
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2022
• 2 Devices were Involved in the Event: 1 2

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: 04/20/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U215
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 02/09/2022; 03/11/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 02/28/2022; 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White