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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the doctor had to explant the tecnis synergy simplicity lens.Additional information was received and it was learnt that poor vision after surgery was the reason for explant.There was no patient injury and no other medical/ surgical interventions were required.The replacement lens details were not provided.The patient was doing great post op.No further information is available.
Additional Manufacturer Narrative
Section a5: ethnicity: unknown, information not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2023 and (b)(6) 2023.Section h3: other 81: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information received that the dfr00v lens with sn (b)(6) was discarded.Based on the additional information received, the code from the initial mdr, type of investigation: 4114 is no longer applicable.The following code have been added to reflect the new information: section h6: type of investigation: code 4115 - device discarded.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: the following sections are updated: section b5 - was reworded with all additional information for better understanding.Section h6: health effect - clinical code: 2138 - visual impairment is replaced with 2227 - halo and 2140 - visual disturbances.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the doctor had to explant the tecnis synergy simplicity lens and complete a lens exchange due to poor vision, halo and glare.There were no other issues after implantation of synergy lens in the patients left eye.There was no patient injury and no other medical/ surgical interventions were required.The replacement lens was a panoptix lens.The patient was doing great post op.The lens is not returned as it was discarded.

• 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: 17819328
• Report Number: 3012236936-2023-02443
• Device Sequence Number: 6124697
• Product Code: MFK
• UDI-Device Identifier: 05050474750715
• UDI-Public: (01)05050474750715(17)240708
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 11/06/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2024
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 10/13/2023; 10/11/2024
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/28/2023; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: Female
• Patient Weight: 82 KG
• Patient Race: White