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

Model Number	ZCU450
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the intraocular lens (iol), model zcu450 with 15.0 diopter power, was implanted in the patient¿s right eye.The iol was explanted in a separate surgical procedure and replaced with a zcu150 model lens with 15.5 diopter power due to visual impairment that was first identified during post-operative examination.It was reported that the patient was temporarily impaired.Account indicated that there were no complications, such as capsular tear, no incision enlargement, no serious patient injury, no unplanned suture(s), and no vitrectomy during the iol explant procedure.Patient outcome post-lens exchange is unknown.It is also unknown if the patient is still temporarily impaired post-lens exchange.No further information was provided.
Additional Manufacturer Narrative
Additional information: patient weight: unknown as information was asked but not provided.Date of event: unknown as information was not provided; the best estimate date is between 31-mar-2022 and 15-jun-2022.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 contact the customer account requesting additional information regarding the complaint; however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 18-aug-2022.Section h-3: device returned to manufacturer: yes.Device evaluation: the complaint lens was received in an unknown solution inside a specimen cup.Visual inspection under magnification revealed the lens was returned cut in half.No defects that could contribute to visual issues were observed.No additional defects were observed.Complaint issue ¿visual disturbance¿ was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 14921580
• Report Number: 3012236936-2022-01687
• Device Sequence Number: 19330165
• Product Code: HQL
• UDI-Device Identifier: 05050474663008
• UDI-Public: (01)05050474663008(17)240924
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: 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): 09/30/2022

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: 09/24/2024
• Device Model Number: ZCU450
• Device Catalogue Number: ZCU450U150
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2019
• 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: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White