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

Model Number	ZMA00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was asking if we knew of any eye covers (like glasses) to cover his eyes and allow him to see while welding, as he is a welder by profession.Both eyes were implanted with an intraocular lens (iol) in 2009.The patient's vision is great during the day, but there is glare when viewing lights at night, and while welding.Patient indicated that when striking an arc while welding, it becomes so distorted that the metal being worked on can no longer being seen.The patient is inquiring if there are any glasses or products that could alleviate the problem.The visual issues are being described as a plumage.It was noted that the patient can still work although they are claiming not really seeing enough.After about 14 months from initial report, patient called back to provide product identifiers.The patient indicated still seeing sparkles at night which blocks the vision.Therefore, the patient claimed not wanting to drive at night anymore.The patient does not work as a welder anymore as he has already stopped welding but did not say when he stopped working as a welder.The patient said that he still welds but only for himself, that is why he really wanted to find out if we are able to advice him on the type of eye wear to use for welding that will help remove the glare while welding.No other information was provided.This mdr report pertains to the right eye (od).A separate report will be submitted for the left eye (os).
Additional Manufacturer Narrative
Section a2, a3b, a4, a5, a6: redacted since complaint reporter was patient.Section b3: date of event: unknown, not provided.Best estimate of date of event is between jul.30, 2009 and mar 31, 2023.Section d6b: if explanted, give date: not applicable, as lens remains implanted.Section h3: the device was not returned for evaluation as lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device 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 - clinical code: 2140 (to capture glare- persistent and visual disturbance dysphotopsia persistent).An attempt has been made to obtain the missing information; however, no definitive response has been received.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: 19628399
• Report Number: 3012236936-2024-000181
• Device Sequence Number: 15227248
• Product Code: MFK
• UDI-Device Identifier: 05050474536852
• UDI-Public: (01)05050474536852(17)140316
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2024

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 Expiration Date: 03/16/2014
• Device Model Number: ZMA00
• Device Catalogue Number: ZMA00U0225
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2009
• 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: Other
• Patient Sex: Male