MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	DIU225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section d6b, if explanted, give date: not applicable as the iol remains implanted.Section h3, device evaluated by manufacturer: the device was not returned for evaluation as it 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.Attempts have been made 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 leading haptic on the preloaded johnson and johnson (jnj) intraocular lens (iol) tore the capsular bag upon insertion.The issue occurred in two cases in two separate surgery centers.This report captures the first case serial #: (b)(6).Reportedly, the doctor is not doing anything different.The doctor thought it might be her but in her second case which is more recent, she injected ophthalmic viscosurgical device (ovd) into the cartridge and the bag was completely inflated with ovd.No resistance was felt upon insertion.No vitrectomy was needed.The iol remains implanted with no complications.We are following-up to get more details and distinction between the two events however, the customer has not responded.No further information was provided.Note.The information for the second case serial #: (b)(6) is being submitted in a separate.Medwatch report, case (b)(4).

• Brand Name: TECNIS IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 20177642
• Report Number: 3012236936-2024-000246
• Device Sequence Number: 8261321
• Product Code: MJP
• UDI-Device Identifier: 05050474747111
• UDI-Public: (01)05050474747111(17)241029
• 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
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

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: 10/29/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U190
• 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: 09/04/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown