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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Blurred Vision (2137); Halo (2227); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had cataract procedure and intraocular lens was implanted in the right eye.On day one post operative examination on (b)(6) 2023, patient stated that it hurt when she put the drops and the near vision has not improved.The patient was advised to continue using prednisolone/moxifloxacin four times a day.On the second post operative visit on (b)(6) 2023, patient's eye was doing well.Patient was disappointed with the halos and rings at night and didn't think the reading was very good with right eye.On the third post operative visit on (b)(6) 2023, patient stated that she had difficulty with halos at night and both computer distance and reading was blurry.Patient was disappointed with haloing and starbursts.It was reported the intraocular lens (iol) was explanted from patient's operative eye due to extreme dysphotopsia and replaced with another monofocal of a slightly lower diopter (23.0d) on the explant first post operative visit (day 1 after the implant of the 23.0d lens), the patient stated that she could see distance fine but cannot read.There was no pain or discomfort.Patient was advised to continue the medication prescribed earlier.Next day, patient reported vision is doing well at distance but the near was not too good.She also reported foreign body sensation that comes and goes.No other information was provided.
Additional Manufacturer Narrative
Patient weight: unknown, asked but not available date of event: unknown, not provided, but the best estimate date is (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 health effect - clinical code: 2137- blurred vision- used to indicate blurred vision and poor near vision.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: 16455678
• Report Number: 3012236936-2023-00513
• Device Sequence Number: 15065811
• Product Code: MFK
• UDI-Device Identifier: 05050474750746
• UDI-Public: (01)05050474750746(17)241222
• 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: 2023
• 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: 12/22/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU235
• 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: 12/22/2021
• 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: 75 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White