MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown; requested but not provided.The best estimate date is between (b)(6) 2022 and (b)(6) 2023.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to product was performed.The search revealed that no similar complaints.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Multiple attempts have been made to obtain additional information regarding the event and to obtain suspect product for evaluation; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported patient had cataract surgery in the left eye.Post operatively there was a refractive surprise and the lens was explanted.The plan was to implant a johnson & johnson lens (different model, zxr00, different diopter of 28.5).An unplanned vitrectomy was required and a three piece lens was implanted instead of the planned zxr00.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 16535070
• Report Number: 3012236936-2023-00655
• Device Sequence Number: 5946320
• Product Code: POE
• UDI-Device Identifier: 05050474605176
• UDI-Public: (01)05050474605176(17)240312
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2023

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: 03/12/2024
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U185
• 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: 02/17/2023
• Initial Report FDA Received Date: 03/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• 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 Sex: Female