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

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Corneal Abrasion (1789); Corneal Edema (1791); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: section a-3a patient sex: unknown/asked information was not provided.Section a-3b patient gender: unknown/asked information was not provided.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 b-3 date of event: unknown/asked information was not provided.Section d-6b date explanted: not applicable as the iol remains implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation as it remains implanted.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.Attempts were made to contact the customer account requesting additional information regarding complaint however, to date no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The dxr00v model intraocular lens (iol) was implanted in the patient¿s ocular sinister (left eye).Patient reports fifteen (15) years ago he had lasik performed.In 2024 he had cataract surgery, it was noted at that time he had some swelling of cornea and a low cell count in the corneal lens.Patient was prescribed medication (prednisone), that he has been taking for eight (08) months.He has not been able to see correctly out of left eye, vision is blurred.His doctor performed a photorefractive keratectomy (prk) and told him if he exchanged the lens, he would also need to replace the cornea.After the prk procedure, the patient experienced leaking, so he saw a cornea specialist who informed him that the eye band aid placed after surgery had been removed too soon.Cornea specialist also told him that he didn't need surgery, but instead that the opening and closing of his eye was not allowing his eye to heal.The cornea specialist placed another eye band aid on him and prescribed him antibiotics for two (02) months.She indicated he had a cornea hole or corneal erosion and referred him back to his original doctor.Since placing the band aid on, the patient stated his eye feels more relaxed.He has lost confidence in his doctor and is trying to research his issues.Also, he was looking into getting a different doctor because there is a long wait to see him.He feels the other doctors in his area are reluctant to assist him out of respect for the doctor he had been using.The patient is also concerned that he may be rejecting the lens or is having an allergic reaction to it because of his poultry/egg allergies.He requested his doctor not be contacted.His ocular dexter (right eye) has his natural lens, with 20/20 vision.The suspect iol is not available for return as it remains implanted.No further information is available.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 22122962
• Report Number: 3012236936-2025-000154
• Device Sequence Number: 20570507
• Product Code: POE
• UDI-Device Identifier: 05050474761797
• UDI-Public: (01)05050474761797(17)250402
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 04/02/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU200
• 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: 05/09/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2022
• 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: Unknown