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

Model Number	DIB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If implanted, give date: not applicable as the iol was removed and replaced during the same procedure.If explanted, give date: not applicable as the iol was removed and replaced during the same procedure.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 the missing information; however, it was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was fully inserted into the patient¿s left eye and then removed.Reportedly, the patient¿s capsule tore.The harm was not the result of the contact with the product.The doctor performed an anterior vitrectomy.A non johnson and johnson lens was used to complete the procedure.There were no other injuries reported and no incision enlargement was required.The suspect product will not be returned as it was discarded.No further information was provided.
Additional Manufacturer Narrative
Corrected data: this is to correct the initial submission.Section a3, gender: it states female but should have stated male.And section b5 said "a non johnson and johnson lens was used to complete the procedure".Also the statement "the harm was not the result of the contact with the product." but correct statement is just "replacement lens information was not provided." the field below is updated: section a3, gender: male.Section b5, describe event or problem: replacement lens information was not provided.Additional information: upon further review new information received that the patient outcome is "doing well".All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: 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: 16665457
• Report Number: 3012236936-2023-00760
• Device Sequence Number: 6586620
• Product Code: HQL
• UDI-Device Identifier: 05050474731615
• UDI-Public: (01)05050474731615(17)250813
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/28/2023

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: 08/13/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0130
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2022
• 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
• Patient Sex: Male