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 Code	Visual Impairment (2138)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section d6a, if implanted, give date: unknown/not provided.Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was implanted into the patient¿s eye.The patient experienced a myopic shift which was impacting their daily activities.The iol was explanted and replaced.The replacement lens information was not provided.There were no complications such as a capsule tear, vitrectomy, or sutures.The patient is doing well.No further information regarding this event is available.
Additional Manufacturer Narrative
Additional information: through follow-up the following details were received.The customer described the mechanical complication of the lens as the result of a myopic shift that affected the patient¿s daily living.Pre and post visual acuity were 20/25 left eye, but the patient was very symptomatic with refractive shift and the target was plano.The implant date is (b)(6) 2025.The customer clarified that the event date is (b)(6) 2025.The iol was explanted and replaced with an alcon lens model ma60ac 19.5 d.Sutures were used at the time of the lens explant, which is the doctor¿s standard practice for an iol exchange.Reportedly, there were no medications outside the standard of care.The patient is in postop period and is still healing.The patient is a white male, 71 years old.174 pounds.Born (b)(6) 1954.The customer said they have already returned the lens.No further information was provided.Section a2, age and date of birth: 71 years old.Date of birth is (b)(6) 1954.Section a3a, sex: male.Section a3b, gender: cisgender man/boy.Section a4, weight: 174 pounds.Section a6, race: white.Section b3, date of event: (b)(6) 2025.D6a.If implanted, give date: (b)(6) 2025.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: 24229188
• Report Number: 3012236936-2026-000029
• Device Sequence Number: 18387641
• Product Code: MJP
• UDI-Device Identifier: 05050474747159
• UDI-Public: (01)05050474747159(17)260420
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: 2026
• 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): 02/09/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2026
• Device Model Number: DIU225
• Device Catalogue Number: DIU225U210
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White