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

Model Number	DRN00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was implanted in the patient's eye.The patient experienced dysphotopsias.The issue was first identified during a post-operative exam.The customer indicated that the directions for use were followed.There is no indication of permanent or temporary impairment.The iol was explanted and the patient was reported as doing well.No further information was provided.
Additional Manufacturer Narrative
Section a3a, sex and a3b, gender: the customer said female.Section a4, a5, a6, patient information: unknown/not provided.Section b3, date of event: the exact date is unknown.The best estimate is between the implant and explant date.(b)(6) 2025 and (b)(6) 2025.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: may 5, 2025.Section h3: evaluated by manufacturer: yes.Device evaluation: the complaint lens was received.Visual inspection under magnification reveal the complaint lens was received cut in half and coated in viscoelastic residue and what appears to be blood.The lens halves were cleaned revealing no issues that could cause or contribute to the complaint issue reported.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.An attempt was made to obtain the missing information.However, it was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 22333854
• Report Number: 3012236936-2025-000175
• Device Sequence Number: 9129054
• Product Code: MFK
• UDI-Device Identifier: 05050474810723
• UDI-Public: (01)05050474810723(17)270814
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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 Model Number: DRN00V
• Device Catalogue Number: DRN00V0180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• 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: 06/17/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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: 51 YR
• Patient Sex: Female