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

Model Number	ZLU375
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a6: unknown/ not provided.Asku.Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section h3- no: the device was not returned for evaluation, as it remains implanted; 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, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was implanted in the patient's right eye.Following insertion of lens, the surgeon reported to the operating room (or) staff that there was some "black stringy material" on the implant.The surgeon was able to irrigate the material off of the implant and out of the eye.The surgeon chose to leave the implant in place.No incision enlargement, vitrectomy, or sutures performed.No other surgical/medical interventions in the future.It was noted that post-op patient was 20/40 at one day post op appointment.Follow up will be done soon.It was learned that there was a planned irrigation and aspiration of the foreign material.Normal routine cataract procedure occurred.However, the foreign material will not be sent back for evaluation.The patient is doing well, there are no issues.No other information was provided.

• 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: 20297310
• Report Number: 3012236936-2024-000261
• Device Sequence Number: 7745357
• Product Code: MFK
• UDI-Device Identifier: 05050474691322
• UDI-Public: (01)05050474691322(17)250408
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2025
• Device Model Number: ZLU375
• Device Catalogue Number: ZLU375U295
• 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: 09/13/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1MTEC, CP12997
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic