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

Model Number	DXR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Sensation in Eye (1869); Visual Impairment (2138); Visual Disturbances (2140); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the surgeon that the preloaded johnson and johnson (jnj) intraocular lens (iol) was explanted from the patient¿s right eye.The doctor said her patient is unhappy with the outcome of her iol and had it explanted by a different surgeon in the area.She does not know the date of the explant.Prior to the explant, the patient called johnson and johnson to report her dissatisfaction.At that time the event was not reportable.The patient reported that after her cataract surgery she experienced visual disturbances and discomfort.She described experiencing light sensitivity, bouncing lights on the right side near light sources, concentric rings of the lens while driving, shadows, double vision resembling a duplicate image in her right eye, and an inability to see clearly out of her right eye.She also noted a 4.5 diopter difference between her eyes, difficulty driving at night, and eye twitching in daylight.Despite being informed that her vision would improve, she stated that it is worse than expected.The patient has consulted her eye doctor five times and was informed by her current surgeon that an exchange to a monofocal lens would be necessary.However, her current surgeon does not perform exchanges, so a different doctor would be required for the procedure.A second opinion doctor indicated that this lens should not have been implanted in a patient with a history of retinal detachment and vitrectomy, which she underwent prior to the lens implant.The patient reported additional challenges with night driving and walking, describing foggy vision, halos, circles, and a sensation of something in her eye at night.No further information was provided.
Additional Manufacturer Narrative
Section a4, patient weight: unknown/not provided.Section a5, ethnicity: unknown/not provided.Section a6, race: unknown/not provided.Section b3, date of event: unknown/not provided.Section d6b, if explanted, give date: unknown/not provided.Device evaluation: the investigation was completed prior to the iol explant.Therefore, no product was returned and product testing could not be performed.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation was required.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.Attempts were made to obtain the missing information.However, it was not provided.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: 23327778
• Report Number: 3012236936-2025-000266
• Device Sequence Number: 10572892
• Product Code: HQL
• UDI-Device Identifier: 05050474761674
• UDI-Public: (01)05050474761674(17)250726
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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: 07/26/2025
• Device Model Number: DXR00V
• Device Catalogue Number: DXR00VU140
• 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: 10/07/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2022
• 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 Age: 56 YR
• Patient Sex: Female