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

Model Number	DRN00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent hypermetropia lasik surgery before implantation of the preloaded multifocal intraocular lens (iol).Account indicated that the lens was implanted, but after the procedure, it was noted that the refractive value was misaligned.As a result, the iol was explanted and replaced with a different lens of a different diopter.Through follow-up, we learned that the affected eye was the right eye.The patient did not experience any injuries, surgical complications, or health issues, and was not hospitalized.No further information was provided.
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: unknown, as information was requested but not provided.Section b3 - date of event: unknown/not available.The best estimate is between implantation date ((b)(6) 2024) and the explant of the lens on (b)(6) 2025.Section e1 - email address: unknown, as information was requested but not provided.Section e1 - telephone number: (b)(6).Section h3: the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not 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 and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: february 19, 2025.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the lens was inspected under magnification.The lens was received cut in half and coated in viscoelastic residue.The lens was cleaned and presented cosmetic scratches on the optic body.No issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction identified.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• 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: 21406029
• Report Number: 3012236936-2025-000023
• Device Sequence Number: 9382062
• Product Code: MFK
• UDI-Device Identifier: 05050474810846
• UDI-Public: (01)05050474810846(17)270507
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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 Model Number: DRN00V
• Device Catalogue Number: DRN00V0240
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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