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

Model Number	DFW150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Flashers (1864); Foreign Body Sensation in Eye (1869); Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: unknown, asked but not available.Ethnicity: unknown, asked but not available.Date of event: unknown, not provided, but the best estimate date is between (b)(6) 2022 and (b)(6) 2023.The device was not returned for evaluation.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.Health effect - impact code: 4644 - medication required- used to indicate the medical intervention and topical steroids.Health effect - clinical code: 4581- eye anatomy issue.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that patient had cataract procedure and intraocular lens was implanted in the left eye.On day one post operative examination on (b)(6) 2022, patient complained of noticing halos since surgery which was worse around lights.The patient was advised to continue using prednisolone/gatifloxacin four times a day.On the second post operative visit on (b)(6) 2022, patient stated that the distance vision was not as clear as should be and there was "barrier" in the vision in the left eye.She was having light sensitivity.The assessment of the surgeon was that the eye was healing well.On the third post operative visit on (b)(6) 2022, patient stated that she sees halos around lights at night and the bright lights are bothersome.Patient felt something in the eye which does not irritate, however, was not sure how to describe it.The patient felt like the distance vision can be improved.Patient was advised to continue prednisolone/gatifloxacin twice a day until drops are finished.On further follow up on (b)(6) 2023, patient was seeing halos and starbursts around lights at night, and was sensitive to sunlight.Both eyes were extremely dry (the other eye still had natural cataract).Patient stated that she could sometimes feel the lens and feels pressure in the eye.The intraocular pressure was 22 mmhg.Patient saw a temporal crescent.The lens was then explanted and replaced with another lens of different model but of same cylindrical and spherical diopter.Lens was explanted from patient's operative eye due to extreme dysphotopsia.Post op explant patient had no pain or irritation and distance vision and glare improved.The next day patient reported that at night saw horizontal line coming from light and was advised to continue medication.No other information was provided.

• 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: 16455552
• Report Number: 3012236936-2023-00516
• Device Sequence Number: 6382002
• Product Code: MFK
• UDI-Device Identifier: 05050474751231
• UDI-Public: (01)05050474751231(17)240415
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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: 04/15/2024
• Device Model Number: DFW150
• Device Catalogue Number: DFW150U185
• 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: 02/03/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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: 71 YR
• Patient Sex: Female
• Patient Race: White