MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZLU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Eye Irritation (4803); Posterior Capsule Opacification (4807)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Section h6: health effect - impact code: 4619 - temporary impairment (this code is used for the reported glare surgical intervention required, halo vision- surgical intervention required & blurry vision issues).Section h6: health effect - impact code: 4613 - minor injury/ illness / impairment (this code is used for the reported dry eye & eye irritation issues).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a multifocal toric intraocular lens (iol) was implanted in the patient¿s right eye.Following implantation, the patient experienced persistent halos, glare, intermittent irritation/dryness and blurry vision, described as continuous and progressively worsening, resulting in decreased quality of both distance and near vision and impacting daily activities.Conservative management, including ocular surface treatment and pharmacologic therapy (vuity), did not provide adequate improvement.The patient ultimately elected to proceed with right eye iol exchange to a monofocal lens and subsequently the lens was explanted.The procedure was successfully completed with implantation of a replacement intraocular lens (model diu150) of the same diopter power as the original lens.Two 10-0 nylon sutures were placed to secure wound closure during the iol exchange procedure.No vitrectomy or other unplanned surgical interventions were required, and no medications outside the standard of care were prescribed.No additional surgical procedures are planned.No patient injury, including capsular tear was reported and no user harm was identified.It was indicated that the visual symptoms were temporally associated with implantation of the original iol; however, the exact etiology could not be definitively determined.Potential contributing factors discussed included posterior capsular opacification (pco) and patient sensitivity to multifocal optics.Following the iol exchange, the patient reported improvement in halos and overall visual satisfaction.The patient outcome was favorable.No further information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 25384016
• Report Number: 3012236936-2026-000157
• Device Sequence Number: 8708987
• Product Code: MFK
• UDI-Device Identifier: 05050474689442
• UDI-Public: (01)05050474689442(17)300505
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 07/14/2026

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: ZLU150
• Device Catalogue Number: ZLU150U240
• 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: 05/08/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White