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

Model Number	ZKB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the zkb00 model intraocular lens (iol) was implanted into the patient¿s ocular dexter (right eye).Due to complaints of lens malfunction, the iol was explanted in a secondary surgical procedure and replaced with a non-j&j iol.There was no incision enlargement, no serious patient injury, no suture(s), and no vitrectomy during the lens exchange procedure.Patient status post-lens exchange is unknown.No further information is available.
Additional Manufacturer Narrative
Additional information: section b-3: date of event: unknown/asked information unavailable.The best estimation date is between (b)(6) 2024 (iol implant and explant dates).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 report will be filed.Section h-6 medical device problem code: 1069 although lens malfunction was reported, it is unknown what the reported issue is for lens malfunction in reference to the explanted intraocular lens (iol).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 28-may-2024.Section h-3: device evaluated by manufacturer: yes.Device evaluation: half of the lens was received in a gauze.The lens was inspected under magnification.The complaint lens was received cut in half with one half missing.The lens presented with damage and a spectrum on the haptic that was within specification.Based on the complaint investigation results, the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction 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: 19356050
• Report Number: 3012236936-2024-000144
• Device Sequence Number: 17093306
• Product Code: MFK
• UDI-Device Identifier: 05050474560130
• UDI-Public: (01)05050474560130(17)261005
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 06/12/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2026
• Device Model Number: ZKB00
• Device Catalogue Number: ZKB00U0225
• 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: 05/09/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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