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

Model Number	TECNIS 1-PC CLEAR MONO 6.0MM 19.0D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Zonular Dehiscence (2698)
Date of Event	08/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a4, a5 and a6: unknown/ not provided section d6b: if explanted, give date: not applicable, as there is no indication that the lens was explanted section e1: reporter: middle name: unknown/ not provided.Section e1: reporter: last name: unknown/ not provided.Section e1: reporter: email address: unknown/ not provided.Section e1: reporter: address: address - line 1: unknown/ not provided.Section e1: reporter: address: address - line 2: unknown/ not provided.Section e1: reporter: city: unknown/ not provided.Section e1: reporter: state, province or territory: unknown/ not provided.Section e1: reporter: telephone number:(b)(6).Section h3: other 81: the device was not returned for evaluation.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the phaco was done until the monofocal non preloaded intraocular lens (iol) insertion.Upon visco removal, it was noted that there was a zonular dialysis 180 degree from 7 o'clock.Iol was removed during same procedure.Vitrectomy was performed and sutures were required.Medications were prescribed.No further information is provided.

• Brand Name: TECNIS IOL
• 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: 20287415
• Report Number: 3012236936-2024-000252
• Device Sequence Number: 15274944
• Product Code: HQL
• UDI-Device Identifier: 05050474531697
• UDI-Public: (01)05050474531697(17)270922
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2024

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 Model Number: TECNIS 1-PC CLEAR MONO 6.0MM 19.0D
• Device Catalogue Number: ZCB0000190
• 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: 08/26/2024
• Initial Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2023
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PHACO SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown