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

Model Number	DRN00V
Medical Device Problem Codes	Application Program Problem: Dose Calculation Error (1189); Use of Device Problem (1670)
Health Effect - Clinical Codes	Corneal Edema (1791); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3b, gender: unknown/not provided.Section a4, patient weight: unknown/not provided.Section a5, ethnicity: unknown/not provided.Section a6, race: unknown/not provided.Section b3, date of event: the exact date is unknown.The best estimate is between the implant and explant dates.(b)(6) 2024 through (b)(6) 2024, respectively.Section h3, device evaluated by manufacturer: the device was not returned for evaluation as it was discarded.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.Follow-up was performed to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was explanted from a female¿s left eye (os=oculus sinister ).The reason is that the patient had a symfony in the first eye (right eye) and wanted more near vision.Therefore, the doctor implanted the odyssey in the left eye (second eye).The patient¿s left eye ended up ½ diopter hyperopic and didn¿t get enough near as a result.Consequently, the doctor decided to adjust for the outcome and switch to another johnson and johnson lens model zcb00 21.5 diopter.The aim is to end up -3.0 so the patient will have good near vision in the that eye.When the event was reported to jnj the patient was j3 with some edema.(j3=20/40 on the jaeger visual acuity eye chart).The doctor thinks if he had hit his target, the patient would have likely been fine.The patient is doing well and seeing j1 (j1=20/25) for near with her jnj replacement lens.No further information was provided.
Additional Manufacturer Narrative
Corrected data.Upon further review it was determined that the initial report provided the incorrect code for section h6, device codes(s).This current report captures the correction below.Section h6, device code(s): 1189 - application program problem: dose calculation error 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: 20164688
• Report Number: 3012236936-2024-000246
• Device Sequence Number: 12585762
• Product Code: MFK
• UDI-Device Identifier: 05050474810709
• UDI-Public: (01)05050474810709(17)260915
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/11/2024

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: 09/15/2026
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0170
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/07/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2023
• 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: 88 YR
• Patient Sex: Female