MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS 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	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4, a5: unknown/ not provided.Asku.Section b3: date of event: unknown, not provided, but the best estimate date is prior to (b)(6) 2023.Section d6a: if implanted, give date: the exact date of implant is unknown, not provided, but the best estimate date is six (6) months earlier than nov 8, 2023.Section h3: (81): 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 additional information regarding the event; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a toric multifocal intraocular lens (iol) was explanted six months after the initial surgery because of the intolerable dysphotopsia that the patient was having.The issue was first identified during post-operational examination.Another johnson & johnson lens of different model (dcb00), a monofocal iol was implanted as a replacement.Unknown if other interventions performed or not.The patient outcome was not provided.No further information was provided.
Additional Manufacturer Narrative
Additional information: the following fields were updated accordingly based on the additional information received from the customer: section a4: patient weight: 193 lbs.Section a5: ethnicity: not hispanic.Section b3: date of event: 6/12/23.Section b5: additional information received indicated that there were no surgical interventions.There was no injury and the patient outcome was reported as "well heald, discussed uncorrected astigmatism, may benefit from limbal relaxing incisions (lri)." the following fields were updated based on the additional information received from the account: section d6a: if implanted; give date: (b)(6) 2023.Section e1: initial reporter email address: (b)(6).Section e1: initial reporter phone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: nov 28, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received for evaluation.Visual inspection reveal that the lens was received in a specimen cup cut in half and with an unknown fluid.The lens was cleaned and presented with no additional issues that would have caused or contributed to the complaint event.The complaint issues "explant" and "visual disturbance- dysphotopsia" were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation, no malfunction or product deficiency was identified.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18243476
• Report Number: 3012236936-2023-03049
• Device Sequence Number: 17792250
• Product Code: MFK
• UDI-Device Identifier: 05050474751163
• UDI-Public: (01)05050474751163(17)240323
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2023
• 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): 01/22/2024

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: 03/23/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/08/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 01/09/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/26/2023; 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2021
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic