MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; LENS, MULTIFOCAL INTRAOCULAR

Model Number	ZKB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Date of Event	01/08/2026
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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the non-preloaded multifocal intraocular lens (iol) was explanted from the left eye (os) due to patient experiencing visual issues, including blurred vision, halos, and glare.The replacement lens is another johnson and johnson, with same model but different diopter ( zkb00 22.0).There was no unplanned incision enlargement, vitrectomy, or sutures required.No additional medical attention or medication prescribed outside of standard of care was required.There was no delay in procedure.The directions for use were followed.Pre-operatively, the best corrected visual acuity (bscva) was 20/40 and 20/25 post-operatively.The patient has fully recovered.Through follow-up, it was noted that the the device did not cause or contribute to the event, and the patient did not report any loss of ability to perform daily activities.The patient experience a loss of two or more lines of bscva.The patient was neither over nor under corrected.Pre-op refraction was -0.75 +1.25 x5, post-op refraction was +0.75 sphere, and the intended target refraction was plano sphere.The post-exchange refraction was +0.50 +0.50 x90.The patient had no pre-existing conditions affecting the calculation.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: feb 10, 2026 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection revealed that the lens was coated in viscoelastic residue with one detached and missing haptic.The lens was cleaned and no further issues were identified.During the product evaluation it was confirmed that the physical characteristics of the lens matched a zkb00 model lens.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The observed during product evaluation could not be confirmed to be related to the manufacturing or design process.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 24433778
• Report Number: 3012236936-2026-000048
• Device Sequence Number: 13323048
• Product Code: MFK
• UDI-Device Identifier: 05050474560109
• UDI-Public: (01)05050474560109(17)270303
• 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: 2026
• 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): 03/26/2026

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: ZKB00
• Device Catalogue Number: ZKB00U0210
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White