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); Posterior Capsule Opacification (4807)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: patient weight: unknown/ asked but not available.Section d6b: if explanted, give date: not applicable as the device remains implanted.Section h3-other (81): the intraocular lens (iol) was not returned for evaluation as the lens remains implanted; 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.Section h6: health effect - impact code: 4625 - yag (yttrium aluminum garnet).Attempts were made to obtain missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was initially reported that an intraocular lens (iol), model drn 23.0 was explanted from a patient¿s right eye (od) due to hyperopic surprise.The replacement lens was of the same model but of a higher diopter (24.5d).No surgical and/or medical interventions required, and no patient injury reported.Before the explant of the original lens the patient¿s correct and uncorrected visual acuity was 20/25 blurry/ best corrected 20/15.In follow ups, it was learned that yttrium-aluminum-garnet (yag) laser procedure was performed on (b)(6) 2024, some days after the replacement lens was implanted in od.It was indicated that the patient had posterior capsular opacification (pco) and the yag performed was mainly done in preparation for touch up.The patient had a film over in od vision.The symptoms to some degree impacted the patient's visual function; however, it was noted that the patient¿s issue was not due to johnson & johnson device.Patients last vision was: visual acuity with distant without correction (dsc) 20/40+1.Pinhole (ph) 20/25-1.No further information was provided.This report pertains to the issues reported on the replacement lens.The issues reported on the original lens did not meet the reportability criteria.

• 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: 18976523
• Report Number: 3012236936-2024-00952
• Device Sequence Number: 6629673
• Product Code: MFK
• UDI-Device Identifier: 05050474810853
• UDI-Public: (01)05050474810853(17)260916
• 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: 2024
• 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): 03/25/2024

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: 09/16/2026
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0245
• 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: 02/29/2024
• Initial Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2023
• 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: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American