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

Model Number	DFW225
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Codes	Visual Impairment (2138); Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2,a3, a4 and a5: unknown/ not provided.Section b3: date of event: unknown/ not provided.Section d6b: if explanted, give date: not applicable, as lens was remained implanted.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
It was reported that dry eye caused an erroneous topography, leading to the incorrect perception of a need for a toric lens.However, the surgeon introduced 2 diopters of cylinder.Initially, the doctor planned to remove the toric intraocular lens (iol) and replace it with a non-toric synergy or odyssey lens.However, additional information suggests that the doctor opted to rotate the lens instead of removing it.The rotation will be more than 10 degrees, specifically from 138 degrees to 165 degrees.As of the patient's last visit, their uncorrected vision improved from 20/80 to 20/30 after the rotation, and the patient seems satisfied with the outcome.Further information suggests that the rotation occurred due to a placement issue.No further treatment or injuries were reported.Additional information received indicated that upon postoperative examination, the patient reported complaints of diplopia and shadowing and these visual complaints have persisted for several months.The patient states that this is affecting all of his daily activities.The doctor would like to exchange the iol for an odyssey toric lens implant.No further details were provided.
Additional Manufacturer Narrative
Additional information: based on additional information received, the lens was explanted and replaced with a different model of j&j iol.As of one week post-operatively, the patient is seeing 20/40 but is still complaining of shadowing the following section have been added to reflect the new information: section h6: health effect - impact code: 4629 - device revision or replacement.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: 21406588
• Report Number: 3012236936-2025-000046
• Device Sequence Number: 21160082
• Product Code: MFK
• UDI-Device Identifier: 05050474751873
• UDI-Public: (01)05050474751873(17)241203
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 04/07/2025

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: 12/03/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U210
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2021
• 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