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 Codes	Eye Injury (1845); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a preloaded monofocal toric intraocular lens (iol) was explanted from the patient's left eye during a secondary surgical procedure.The specific reason for the explant was not provided.The patient¿s daily activities were not significantly affected.The patient underwent a vitrectomy, but no incision enlargement, sutures, or delay in the procedure occurred.No medications were prescribed, and no additional medical attention were necessary.The patient has fully recovered.Pre-operative vision was 20/50 with correction, and post-operative vision improved to 20/20 with correction.It was confirmed that the instructions for use were followed.No further information was provided.
Additional Manufacturer Narrative
Section a4, a5, a6: unknown, information was requested but not provided.Section h3: the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain additional information regarding the event; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: additional information received indicated that the reason for explant was patient's symptom, the vision affected by lens position which was noted immediately after surgery.It was confirmed that the vitrectomy was performed because of a capsule tear and that was added that according to the surgeon who explanted the lens, it was a possibility pre-op, and then it was deemed necessary during the surgery.The replacement lens model and diopter is unknown.It is unknown if the patient had any pre-exiting issue which contributed to the reported event.No further information was provided.The following fields were updated based on the provided information: section a5: ethnicity: non-hispanic/latino section a6: race: white section h6: health effect - clinical code: 2639 - capsular bag tear.Section h6: health effect - clinical code: 4581 - this code was used for the reported device decentered or dislocated.Corrected data: based on the additional information provided, the following code is no longer applicable: section h6: health effect - clinical code: 1845 - eye injury.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 22751525
• Report Number: 3012236936-2025-000214
• Device Sequence Number: 9558377
• Product Code: MJP
• UDI-Device Identifier: 05050474747043
• UDI-Public: (01)05050474747043(17)270808
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 09/03/2025

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: DIU225
• Device Catalogue Number: DIU225U155
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2024
• 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: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White