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

Model Number	DFW375
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during insertion, the dfw375 intraocular lens (iol) was scratched on advancement.There was patient contact however, extent is unknown.Another johnson & johnson lens with the same model and diopter size was implanted.There was no patient harm or injury and no medical or surgical intervention.Patient is doing fine post-operatively.No further information is available.
Additional Manufacturer Narrative
Patient weight and a-5 ethnicity and race: unknown/asked information unavailable.Date implanted: not applicable as the iol was not implanted.Date explanted: not applicable as the iol was not implanted, therefore not explanted.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 were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.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: date returned to manufacturer: 07-mar-2023.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the complaint lens and handpiece were received inside of a bag in the original folding carton.Visual inspection under magnification revealed that the complaint lens was received cut into three pieces.The lens was cleaned and, a punctured hole in the middle piece could be observed.Based on the return condition of the lens, no further product evaluation could be performed.Visual inspection under magnification of the handpiece revealed that it was received with the plunger rod advanced.The cartridge tip and cartridge could be observed to have a stress mark that exceeded acceptable bounds.Complaint issue of ¿dc-cosmetic issues¿ was not confirmed.The other observed issues found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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: 16464905
• Report Number: 3012236936-2023-00507
• Device Sequence Number: 7671876
• Product Code: MFK
• UDI-Device Identifier: 05050474752856
• UDI-Public: (01)05050474752856(17)250316
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/20/2023

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: 03/16/2025
• Device Model Number: DFW375
• Device Catalogue Number: DFW375U110
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2022
• 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
• Patient Sex: Female