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	Inflammation (1932); Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to patient was not happy with her vision.The patient complained of distance blurry, blind white spot while reading, and visual acuity (va) fluctuates, but mostly fuzzy all the time.At 3-weeks post-operative (op), patient says eye still feels swollen and uncomfortable with more distance blur than near blur.Therefore, the lens was exchanged for another johnson & johnson lens (same model and lower diopter) as a replacement lens.The incision was enlarged, however, no vitrectomy or sutures were required.There was no patient injury reported.The patient is doing great post-explant.No additional information was provided.Visual acuity pre-operative: 20/40.Visual acuity post-operative: 20/20.
Additional Manufacturer Narrative
Age: unknown, information not provided.Patient weight: unknown, information not provided.Ethnicity/race: unknown, information not provided.The device was not returned for analysis; 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.An attempt has been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 2/7/2022.Section h3: device evaluated by manufacturer : yes.Device evaluation: the complaint lens was received inside a specimen cup submerged in an unknown solution.Visual inspection under magnification revealed that the lens was received cut in half, which is consistent with a lens that was handled during explant.No handpiece was received as part of this return, therefore no product evaluation could be performed on the handpiece.Based on the return condition of the lens, the complaint issue could not ne confirmed, and no product deficiency could be identified.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: 13391043
• Report Number: 3012236936-2022-00246
• Device Sequence Number: 17338234
• Product Code: MFK
• UDI-Device Identifier: 05050474751286
• UDI-Public: (01)05050474751286(17)240706
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/28/2022

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: 07/06/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U210
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2021
• 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