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

Model Number	DFW225
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
Weight, and ethnicity: unknown/no information.Date of event: exact date unknown/not provided.Best estimate date is between 7/6/2021-8/17/2021.The device is not returning for evaluation as indicated by the customer.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that the patient had issues with the synergy intraocular lens (iol).An exchange was performed bilaterally.Through follow-up, the customer clarified that the affected eye was the right eye.The reason for the explant is that the patient was off target and unhappy with the outcome.Their vision pre-operative on (b)(6) 2021 was 20/100 and post-operative in (b)(6) 2021 was 20/60.The customer also explained that the incision was not enlarged, no vitrectomy and no sutures were required.There was no delay in procedure.Medication was prescribed, but there's no indication that they were not part of the regular medical regimen.Additionally, it was explained that the symptoms persisted for about 1 month.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS IOL
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 12530583
• Report Number: 2020664-2021-07393
• Device Sequence Number: 17435555
• Product Code: POE
• UDI-Device Identifier: 05050474751637
• UDI-Public: (01)05050474751637(17)240419
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 04/19/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR