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

Model Number	DIU300
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: female section a-4 patient weight: unknown information was not provided.Section a-5 patient ethnicity: unknown information was not provided.Section a-6 patient race: unknown information was not provided.Section b-3 date of event: unknown information was not provided.The best date estimation is between 21-jul-2025 and 03-sep-2025 (iol implant and explant dates).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 and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The diu300 model intraocular lens (iol) was implanted in the patient¿s eye.In a secondary surgical procedure, the iol was explanted due to complaints a of mechanical complication resulting in decreased visual acuity, and replaced with diu300 18.0 iol.There was no incision enlargement, no sutures, and no vitrectomy during the lens exchange procedure.Patient prognosis post lens exchange was reported as good.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-9: device available for evaluation: yes.Section d-9: device date returned to manufacturer: 12-jan-2026.Section h-3: device evaluated by manufacturer: yes.Device evaluation: the lens was received inside a specimen cup.During a visual inspection, the device was inspected under magnification.The lens was cut in half and coated in viscoelastic residue.No issues that could contribute to the complaint issue were observed.During the product evaluation it was confirmed that the physical characteristics of the lens matched a diu300 model lens.No further evaluation was performed.The complaint issue "mechanical issue" was not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.The lens diopter results obtained from the miq electronic system show that this production order was released within diopter specifications.A search revealed that no other complaints have been received for this production order.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction was 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: 23786089
• Report Number: 3012236936-2025-000335
• Device Sequence Number: 21444677
• Product Code: MJP
• UDI-Device Identifier: 05050474747715
• UDI-Public: (01)05050474747715(17)280404
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 01/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIU300
• Device Catalogue Number: DIU300U195
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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: 74 YR
• Patient Sex: Female