MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	DFW225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Capsular Bag Tear (2639)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3-other (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 an attempt was made to obtain the missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was explanted from the patient's left eye since the patient could not see near or distance good enough.The patient did not have any pre-existing medical history issues and did not have debilitating condition.A non-johnson & johnson light adjustable lens was used as a replacement.It was indicated that there was capsule tear, and an unplanned vitrectomy was performed.There was no incision enlargement.The patient outcome was reported to be ok.No further information was provided.Patient had bilateral lens implants.This report captures the issues reported on the lens in patient¿s left eye.A separate report has already been filed for the right eye of the patient.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: aug 1, 2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was received and evaluated.Visual inspection under magnification revealed that the complaint lens was received cut in half and with both haptics detached.The lens was cleaned and, no issues that could cause or contribute to the complaint issue.Based on the return condition of the lens, no further product evaluation could be performed.Conclusion: based on the investigation, no malfunction or product deficiency was identified and the complaint issue reported could not be confirmed.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: 17132220
• Report Number: 3012236936-2023-01493
• Device Sequence Number: 6458105
• Product Code: MFK
• UDI-Device Identifier: 05050474751705
• UDI-Public: (01)05050474751705(17)240226
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: 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
• Report Date (Section B): 09/05/2023

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: 02/26/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U125
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White