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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) is planned to be removed from the patient's right eye due to very bothersome glare/halos.Further follow-up confirmed that the iol was explanted and replaced with diu150, 17.0d.No incision enlargement, no vitrectomy and no sutures done.No patient post-explant injuries, patient fine post-op.Product already returned to us yesterday.No other information was provided.
Additional Manufacturer Narrative
Section a5: ethnicity: unknown/ not provided.Asku.Device evaluation: product evaluation was not performed because the product has not been received.The complaint issue reported could not be confirmed and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no other complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: apr 19, 2023.Section h3.Device evaluated manufacturer? yes.Device evaluation: product evaluation was performed under magnification.No handpiece was received for evaluation.The complaint lens was received cut into pieces.No issues that would have contributed to the complaint event were identified.The complaint issues were not confirmed.The other observed issue during product evaluation could not be confirmed to be related to a manufacturing or design issue.As per complaint investigation results, the product was released within specifications.Relationship between the device and the reported incident could not be determined.Conclusion: as a result of the investigation therefore, there is no indication of a product deficiency or product malfunction.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: 16765999
• Report Number: 3012236936-2023-00720
• Device Sequence Number: 16874009
• Product Code: MFK
• UDI-Device Identifier: 05050474751217
• UDI-Public: (01)05050474751217(17)240612
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/12/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U175
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2021
• 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 Age: 69 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White