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

Model Number	DRN00V
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a3b, a4, a5, a6: unknown/ asked but not available.Section d6a: if implanted, give date: not applicable, as it remains implanted.Section d6b: if explanted, give date: not applicable, as it remains implanted.Section h3: the device was not returned for evaluation and the serial number for this device is unknown/not provided; therefore, no further product investigation can be performed.Should any further relevant information become available a supplemental medwatch will be filed.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It is reported that a bundle of fibers was observed on the multifocal intraocular lens, with some fibers appearing to be wrapped around the optic.The lens was not explanted and remains in the patient's eye.Additional information suggests that this observation was made during implantation/application.No injury or intervention was required however required extra time to removed fibers.The status of the patient is unknown.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes section d-9: device date returned to manufacturer: aug 22, 2024 section h-3: device evaluated by manufacturer: yes device evaluation: photos were provided by the customer and evaluated.The photos shows an eye implanted with the suspect lens and three hair-like fibers can be observed on the lens.The fibers observed were circled by the customer.A failure investigation (fi) was initiated to further examine the issue.Visual inspection of the complaint device reveal that it was received with the plunger rod fully retracted.No foreign material was observed through external visual inspection.The lens module was opened and no foreign material was observed.Conclusion: based on the complaint investigation and product evaluation results further investigation is required.A failure investigation (fi) is being performed to further investigate this complaint issue.The complaint issue reported was verified.Based on the analysis of the returned device, there is no indication of product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 20042691
• Report Number: 3012236936-2024-000229
• Device Sequence Number: 7955080
• Product Code: MFK
• UDI-Device Identifier: 05050474810815
• UDI-Public: (01)05050474810815(17)270411
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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 Model Number: DRN00V
• Device Catalogue Number: DRN00V0225
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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 Age: 70 YR
• Patient Sex: Female