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

Model Number	DFR00V
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-operatively the iol (intraocular lens) dislocated due to bag instability.The iol was explanted from the patient¿s right eye.The replacement lens model zma00 21.5 diopter was placed into the sulcus.However, it also dislocated.Therefore, the replacement lens was also explanted and replaced with a non-johnson and johnson (jnj) iol.The non-jnj lens was placed in the anterior chamber.No further information was provided.
Additional Manufacturer Narrative
Age, weight and ethnicity: information unknown/asku.Date of event: the exact date is unknown.The best estimate is between the implant and explant dates.(b)(6) 2023.Health effect - clinical code: 4581 used to capture device decentered or dislocated or tilted subluxated or wrong position, device dislocation.The device has not been 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 have been made to obtain the missing information; however, to date, it has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information was received from the customer stating the suspect iol was discarded.The following field was updated accordingly.Section h6, type of investigation: 4115 - device discarded.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: 16492658
• Report Number: 3012236936-2023-00491
• Device Sequence Number: 12374966
• Product Code: MFK
• UDI-Device Identifier: 05050474750715
• UDI-Public: (01)05050474750715(17)240928
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 04/21/2023

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: 09/28/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU220
• 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: 02/16/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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 Sex: Unknown