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

Model Number	ZKU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The best estimate date is between oct 12, 2022 and mar 15, 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.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the wrong power intraocular lens (iol) was used, so the lens was explanted from the left eye in a secondary procedure.A non-johnson and johnson iol was implanted as replacement (3-piece monofocal, different diopter of 18.0).There was no patient injury and no medical or surgical intervention was indicated.It is unknown how the patient is doing post-operative.Through follow-up, it was learned that the reason for explant was that the patient could not tolerate the multifocal.After about a month of trying to adapt to the multifocal, the patient could not.Pre-operative best corrected visual acuity (va) was 20/20.Post-operative (initial implant) best corrected va was 20/20.The intended target refraction was plano.Post-operative best corrected visual acuity (post-replacement implant) was 20/20.There was no calculation issue.The patient outcome at discharge was good.No further information was provided.
Additional Manufacturer Narrative
The product was returned for evaluation.Additional information received reported that no wound enlargement, suture, or vitrectomy was required and there were no complications.Amvisc viscoelastic and platinum injector were used with the intraocular lens (iol).The patient age at the time of the event was 70 years old.No further information was provided.Additional information: section a2: age: 70 year(s).D10: concomitant medical products: amvisc, platinum injector.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: apr 24, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint lens was received cut in half and no defects were observed before and after cleaning the lens.No defects that could contribute to visual issues were observed.Based on the return condition of the lens no further evaluation could be performed.The complaint issue was not confirmed.The other observed issue during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as per complaint investigation results, the product was released within specifications.A relationship between the device and the reported incident could not be determined.The complaint issue reported could not be confirmed; 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: 16748035
• Report Number: 3012236936-2023-00930
• Device Sequence Number: 19690381
• Product Code: MFK
• UDI-Device Identifier: 05050474686991
• UDI-Public: (01)05050474686991(17)250326
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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: 03/26/2025
• Device Model Number: ZKU150
• Device Catalogue Number: ZKU150U185
• 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: 03/20/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC, PLATINUM INJECTOR; PLATINUM CARTRIDGE, UNKNOWN LOT #
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female