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

Model Number	ZLB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Visual Impairment (2138); Halo (2227); Zonular Dehiscence (2698)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3b: unknown/ asked but not available.Device evaluation: at the time of the investigation, device was not available for evaluation, therefore no testing could be performed.The reported event cannot be confirmed.Manufacturing record review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: based on the investigation results there is no indication of a product quality deficiency.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the multifocal lens (iol) was explanted due to contraction issues.The iol was the correct model and power, but the patient had complaints of halos and ghost images, possibly indicating a peripheral capsular tear or zonular dehiscence.The physician observed these possibilities.The lens was removed and replaced during a secondary surgical procedure with an unknown iol.The patient mentioned experiencing blurry vision and the outcome is yet to be determined.No other interventions have been needed.No further information was provided.
Additional Manufacturer Narrative
Upon receiving additional information, the surgeon reported that the patient is doing well and vision is 20/25.The capsule exhibited some zonular weakness and was replaced with an intraocular (iol) from another company.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: 20257317
• Report Number: 3012236936-2024-000239
• Device Sequence Number: 12765930
• Product Code: MFK
• UDI-Device Identifier: 05050474560604
• UDI-Public: (01)05050474560604(17)270426
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/09/2024

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: ZLB00
• Device Catalogue Number: ZLB00U0165
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2023
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White