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

Model Number	DIB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3b patient gender: male section a-4 patient weight: unknown/asked information was not provided.Section a-5 patient ethnicity: unknown/asked information was not provided.Section a-6 patient race: unknown/asked information was not provided.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 dib00 model intraocular lens (iol) was implanted in the patient¿s ocular dexter (right eye).Post-operatively, the patient had blurry vision, thus the iol was explanted in a secondary surgical procedure and replaced with a lower diopter iol, replacement lens model information was not provided.Patient prognosis post lens exchange was reported as fully recovered, with no significant impact on daily activities.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: 05-nov-2025.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 cleaned and no issues were identified.During the product evaluation it was confirmed that the physical characteristics of the lens matched a dib00 model lens.No further evaluation was performed.The complaint issues reported were not confirmed during product evaluation, and no other issues were identified.The manufacturing records for the product were reviewed; the units were released in accordance with specifications.A search revealed that no other complaints have been received for this production order (po) number.Conclusion: 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 SIMPLICITY
• 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: 23468090
• Report Number: 3012236936-2025-000289
• Device Sequence Number: 8807203
• Product Code: HQL
• UDI-Device Identifier: 05050474731769
• UDI-Public: (01)05050474731769(17)280723
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2025

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 Model Number: DIB00
• Device Catalogue Number: DIB00U0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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: 65 YR
• Patient Sex: Male