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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided; but the best estimate date is between may 17, 2023 and feb 13, 2024.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 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.
Event or Problem Description
It was reported that a multifocal intraocular lens (iol) was explanted from a patient¿s right eye as the patient had very symptomatic glare, halo, and starburst.The issue was first noted during the post-operative examination.No other surgical and/or medical interventions required and no delay in procedure reported.Another johnson & johnson lens from different model (zcb00) but of the same diopter was used as a replacement.The patient is doing well post-operation and no injury was reported.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: mar 21, 2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens was visually inspected under magnification revealing that the lens was cut in half.The lens was further inspected, and no issues that could cause or contribute to the compliant issues were observed.The complaint issue "explant", "glare", "halo vision", and "visual disturbance - starburst" 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: 18862511
• Report Number: 3012236936-2024-00632
• Device Sequence Number: 15513896
• Product Code: MFK
• UDI-Device Identifier: 05050474750579
• UDI-Public: (01)05050474750579(17)240610
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 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): 04/08/2024

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: 06/10/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU150
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White