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

Model Number	ZKU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the non-preloaded multifocal toric intraocular lens (iol) was explanted from the right eye due to the patient experiencing halos and poor night vision.The patient was able to perform daily activities as before the surgery.The best corrected visual acuity (bcva) both preoperatively and postoperatively was 20/20.No unplanned incision enlargement, vitrectomy, or sutures were required.There was no delay in the procedure.The patient¿s status is temporarily impaired.The directions for use were followed.Through follow-up, it was confirmed that the replacement lens was a non¿johnson & johnson lens.The device contributed to the event.The patient was neither over-corrected nor under-corrected and did not experience a loss of 2 or more lines of best spectacle-corrected visual acuity (bscva).The intended target refraction was plano.The patient had no pre-existing conditions that would affect the calculation, and no medication outside the standard of care was prescribed.No further information was provided.
Additional Manufacturer Narrative
Section a4: weight: unknown/ requested but 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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 4, 2026.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection revealed that the lens was received cut in half and coated in viscoelastic residue.The lens halves were cleaned revealing a haptic was detached from one lens half and scratches were observed on the other.The physical characteristics of the received lens was confirmed to match that of a zku150 model lens.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.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: 24284719
• Report Number: 3012236936-2026-000032
• Device Sequence Number: 18607440
• Product Code: MFK
• UDI-Device Identifier: 05050474687073
• UDI-Public: (01)05050474687073(17)250330
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/11/2026

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 Expiration Date: 03/30/2025
• Device Model Number: ZKU150
• Device Catalogue Number: ZKU150U225
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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: 51 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White