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

Model Number	DIU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2005
Type of Reportable Event	Serious Injury
Event or Problem Description
The diu150 model intraocular lens (iol) was removed and replaced from the patient¿s ocular sinister (left eye) during the same procedure to place a 3-piece lens after being fully inserted.Vitrectomy, yamani technique to secure the 3-piece lens, sutures, and a one (01) hour procedural delay were reported during the initial surgery however, it is unknown if the incision was enlarged.There was no medical attention and no medication prescribed (outside of standard care).The iol directions for use were followed.Patient prognosis post-procedure was reported as fully recovered.No further information is available.
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: male.Section a-6 patient race: unknown as information was not provided.Section d-6a date implanted: not applicable as the iol was removed and replaced during the initial procedure.Section d-6b date explanted: not applicable as the iol was removed and replaced during the initial procedure; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint 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 report will be filed.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: 22778863
• Report Number: 3012236936-2025-000215
• Device Sequence Number: 9342208
• Product Code: MJP
• UDI-Device Identifier: 05050474746602
• UDI-Public: (01)05050474746602(17)260721
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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 Expiration Date: 07/21/2026
• Device Model Number: DIU150
• Device Catalogue Number: DIU150U230
• 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: 07/22/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic