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 Code	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that preloaded multifocal intraocular lens(iol) was explanted and replaced with different lens as the patient complained about dysphotopsia.No other information is available.
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2021 and (b)(6) 2023.Section d6a: implant date unknown/not provided.Section d6a: explant date unknown/not provided.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 and complaint history for production order for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: device date returned to manufacturer: 07-aug-2023.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the complaint lens was received cut in half and with both haptics detached.The lens was cleaned and, no issues that could cause or contribute to the complaint issue could be identified.Based on the return condition of the lens, no further product evaluation could be performed.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order was performed.The search revealed that no other complaints were received for this purchase order.Conclusion: the complaint issue reported could not be confirmed and no product deficiency or product malfunction could be identified.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: 17501311
• Report Number: 3012236936-2023-02021
• Device Sequence Number: 15079156
• Product Code: MFK
• UDI-Device Identifier: 05050474750623
• UDI-Public: (01)05050474750623(17)240330
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/02/2023

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: 03/30/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU175
• 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: 07/17/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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: Unknown