MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. 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	Visual Disturbances (2140); Halo (2227); Discomfort (2330)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3: other 81: 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
A patient expressed dissatisfaction with an intraocular lens that had been implanted in their left eye.The patient reported experiencing poor near vision and difficulty seeing compared to their pre-surgery vision.The patient initially complained of experiencing halos and night glare, which significantly interfered with their daily activities.The lens was explanted and replaced with a dib00 lens.The patient's post-operative uncorrected and best corrected visual acuity was 20/25, and no other injuries or medical interventions were necessary.No additional information was provided.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes section d9: returned to manufacturer on: 4/18/2023 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification revealed that the lens was received cut in pieces with no further cosmetic defects before and after cleaning.No defects that could contribute to visual issues were observed.Based on the returned condition of the lens no further evaluation could be performed.Conclusion: the complaint issues were not confirmed during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications and a relationship between the device and the reported incident could not be determined.The complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.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 PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16854723
• Report Number: 3012236936-2023-01082
• Device Sequence Number: 7566764
• Product Code: MFK
• UDI-Device Identifier: 05050474750562
• UDI-Public: (01)05050474750562(17)241110
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 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): 07/03/2023

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: 11/10/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU145
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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 Sex: Female