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 Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6b: if explanted, give date: not applicable, as the lens remains implanted.Section h6: health effect - clinical code: 2140 glare, 2140 visual disturbance- dysphotopsia.Device evaluation: the device was not returned to the manufacturing site as it remains implanted; therefore, product testing could not be performed, and the reported complaint could not be verified.Manufacturing record 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 similar complaints for this po number have been received.Conclusion: based on the complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.Attempts were made to obtain additional 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 after the intraocular lenses (iols) were implanted in both eyes, the patient experienced glare from headlights and bright light disbursements surrounding objects at night and while driving, along with giant size light areas being emitted from the lens at night diminishing the ability to perceive speed and distance.The patient also experienced peripheral glare from office background lighting and peripheral light from the sun which caused the lens edge to be noticeable causing vision to have perimeter interference from the lens.Additionally, the patient experienced seeing bright spots and halos around lights appearing during computer monitor use and it was noted that the lenses fail to function with led computer monitor spectrum.The patient further reported that the center prism of both optics is apparent and interferes with vision while working.The symptoms were first noted immediately after surgery, which was reported to the doctor within hours.The patient sought a second and third clinical opinion, which indicated that surgery would not resolve the issues.No interventions were indicated or reported.Additional information was received reporting that the patient is still experiencing "thick peripheral vision interference".No further information was provided.This report is to capture the event for the right eye.A separate report will be submitted to capture the left eye event.
Additional Manufacturer Narrative
Additional information: additional information was received on voluntary medwatch form mw5178369 (right eye) reporting that cataract surgery resulted in peripheral distortion which was diagnosed by doctor as ¿thick peripheral blocked¿ induced by doctor, believed defective lenses.No further information was provided.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: 23589849
• Report Number: 3012236936-2025-000306
• Device Sequence Number: 16003887
• Product Code: MJP
• UDI-Device Identifier: 05050474747166
• UDI-Public: (01)05050474747166(17)270201
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: DIU225
• Device Catalogue Number: DIU225U215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White