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	Blurred Vision (2137)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section d6b, if explanted, give date: not applicable as the device has not been explanted.Section h3, device evaluated by manufacturer: a review of records related to the device including labeling and complaint trending will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.The device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The following was reported about the preloaded johnson and johnson (jnj) odyssey intraocular lens (iol).The customer had a patient that is extremely unhappy with his vision with the odyssey lens to the point that the patient has had a terrible car accident.The surgeon's plan is to exchange his iols and replace them with vivity (a non johnson and johnson iol).The explants have not occurred however, the symptoms were reported as debilitating as there are several activities that the patient can no longer perform that they could prior to the surgery.Some of the activities are driving, motorcycling and reading.Reportedly, there was no incision enlargement, vitrectomy, sutures or delays in procedure.The end-user did not seek medication attention outside the standard of care.No further information was provided.
Additional Manufacturer Narrative
Additional information: through follow-up the customer provided additional details.The intraocular lens (iol) was explanted (b)(6) 2025.The patient outcome was reported as unknown.Confirmed the patient¿s date of birth is (b)(6) 1965.This current report is to provide this information section a2, date of birth: (b)(6) 1965.Section d6b, if explanted, give date: (b)(6) 2025.Section h6- health effect - impact code: 4629 used to capture the explant of the iol.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information.The johnson and johnson investigation team commented the following regarding the intraocular lens (iol) that had been returned and reported in manufacturer report number 12236936-2025-0001061, follow-up #1.Comment: since it cannot be determined which investigation this lens belongs to manufacturer report number 12236936-2025-0001061 or manufacturer report number 3012236936-2025-0001062 the lens will be evaluated in both investigations.Following are the investigation results for manufacturer report number 3012236936-2025-0001062.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jun 18, 2025.Section h3: evaluated by manufacturer? yes.Device evaluation: the lens was visually inspected under magnification revealing that the lens was coated in viscoelastic residue with one haptic detached and missing.The lens was cleaned and inspected.No further issues were identified.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & 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: 21859397
• Report Number: 3012236936-2025-000106
• Device Sequence Number: 4721549
• Product Code: MFK
• UDI-Device Identifier: 05050474810761
• UDI-Public: (01)05050474810761(17)270627
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 10/10/2025

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: DRN00V0200
• 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: 03/20/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 10/07/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/12/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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: Other
• Patient Sex: Unknown