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 Disturbances (2140)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a4: weight: unknown/not provided.Section a5: ethnicity: unknown/not provided.Section a6: race: unknown/not provided.Section h3: the 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 will be filed.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a single-piece preloaded toric intraocular lens (iol) was explanted from the patient¿s left eye due to negative dysphotopsia.After implantation, the patient experienced symptoms that were described as shadows and flashes from the left eye radiating to the right eye.The symptoms persisted for approximately three months.The original lens was subsequently explanted during a secondary surgery and replaced with a non¿johnson & johnson iol with a 22.0-diopter power.No unplanned surgical interventions, such as incision enlargement, sutures, or vitrectomy, were required.No delay in the procedure.It is unknown if any medication was prescribed that was outside of the standard of care.Directions for use was followed.The patient has fully recovered.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Device evaluation: visual inspection revealed ovd on the surface of the lens.The lens was cleaned and further inspected; no further issues were identified.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.The following fields were updated accordingly: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: feb 03, 2026.Section h3: device evaluated by manufacturer: yes.Section e1: title (e.G., mr., ms.): dr.Section e1: first/given name: (b)(6).Section e1: last name: (b)(6).Section e2: health professional?: yes.Section e2: occupation: physician.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: 24227810
• Report Number: 3012236936-2026-000027
• Device Sequence Number: 10175491
• Product Code: MJP
• UDI-Device Identifier: 05050474747173
• UDI-Public: (01)05050474747173(17)271018
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/11/2026

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 Model Number: DIU225
• Device Catalogue Number: DIU225U220
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2024
• 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: Male