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	Visual Impairment (2138); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3b: unknown/ asked but not available.Section h3: 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 preloaded intraocular lens(iol) was explanted from patient's right eye due to patient experiencing refractive surprise.The patient's desire was plano but outcome resulted in a visual acuity of -1.25.The issue was first identified after t implanted/application of the lens and visual issues were observed the following day.The lens was fully inserted, removed and replaced with the same model lens with 22.0 diopter in a secondary procedure.Pre-op best spectacle corrected visual acuity (bscva) 20/30 and bscva post op 20/20.No other information is available.
Additional Manufacturer Narrative
Correction: in reviewing the initial mdr 3012236936-2025-0000359, it was noticed that the following "event description and clinical code" codes were inadvertently included; therefore, it is captured in this supplemental report.The following fields have been updated accordingly: the patient's desired refraction was plano, but the outcome resulted in a refractive error of approximately -1.25 d.The lens was fully inserted and subsequently removed.It was replaced with the same model lens, specifically diu300 +22.0 diopters, during a secondary procedure.Post-operative best corrected visual acuity (bscva) improved from 20/30 preoperatively to 20/20.Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: april 3, 2025.Section h-3: device evaluated by manufacturer: yes.Section h6: health effect - clinical code: 2138 - visual impairment.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected and damage on the edge of the lens was observed.No further evaluation was performed.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other issues observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.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: 21370643
• Report Number: 3012236936-2025-000035
• Device Sequence Number: 8482390
• Product Code: MJP
• UDI-Device Identifier: 05050474747210
• UDI-Public: (01)05050474747210(17)241109
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 11/09/2024
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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; Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White