MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: unknown/ not provided.Asku.Section b3: date of event: unknown, not provided.Section d6a: if implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Section d6b: if explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Therefore, it was not explanted.Section e1: email address: unknown/not provided.Section h3-other (81): 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.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted/removed because bag assembly was not able to support the iol.The iol was not saved.No other information was provided.
Additional Manufacturer Narrative
Additional information and corrected data: new information confirmed that for this event, the original implant date was (b)(6) 2024.A day post-op, on (b)(6) 2024, the surgeon noticed that the lens dislocated due to bag assembly not able to support the lens.Instead of lens being removed and replaced during the same procedure as initially reported, a secondary surgical intervention of explant was done on (b)(6) 2024.Explanted lens was replaced with an ar40e lens.Patient well post-op.No other adverse events.Codes updated accordingly.This report is being submitted to correct and report new information received.Fields below updated: section b3: date of event: jun.07, 2024.Section d6a: implant date: (b)(6) 2024.Section d6b: explant date: (b)(6) 2024 section h6: health effect: impact code: 4629 (explant).Section h6: health effect: clinical code: 4581 (to capture device decentered or dislocated or tilted subluxated or wrong position: device dislocation).Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19726739
• Report Number: 3012236936-2024-000195
• Device Sequence Number: 20841517
• Product Code: POE
• UDI-Device Identifier: 05050474761858
• UDI-Public: (01)05050474761858(17)250729
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 07/29/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU230
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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: Unknown