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

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/15/2025
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 this review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a non-preloaded, multifocal intraocular lens was implanted in a patient who later experienced hazy, foggy, and cloudy vision in her right eye.The issue was identified during a post-operative examination.The lens was explanted and replaced with a non-johnson & johnson lens of 21.5 diopter.The patient's pre-operative best corrected visual acuity (bscva) was 20/30+2 and bscva post-operative was 20/20+1.No unplanned complications, such as incision enlargement, sutures, or vitrectomy, occurred during the secondary surgery.There were no delays in the procedure, and no medical attention or prescribed medications outside of standard care were reported.The patient has fully recovered.The direction for use of the device was followed.No further information provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Date returned to manufacturer: nov 12, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was coated in viscoelastic residue.The lens was cleaned and further inspected, and no issues were observed.During the product evaluation it was confirmed that the physical characteristics of the lens matched a zkb00 model lens.No further evaluation was performed.The complaint issues reported could not be confirmed during product evaluation, and no issues were identified.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.All pertinent information available to johnson & johnson surgical vision inc.Has been submitted.

• 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: 23441704
• Report Number: 3012236936-2025-000280
• Device Sequence Number: 8552295
• Product Code: MFK
• UDI-Device Identifier: 05050474560123
• UDI-Public: (01)05050474560123(17)281009
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/26/2025

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: ZKB00
• Device Catalogue Number: ZKB00U0220
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White