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	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) was implanted into the patient¿s right eye.During a post-operative exam the patient reported that their computer vision is terrible and their reading is not good.The iol was explanted in a secondary surgery and replaced with a non-johnson and johnson lens model en+21.0.The patient¿s best corrected visual acuity (bcva) pre-operatively was reported as 20/20 -1.Post-operative bcva was 20/20 -1.The customer indicated that they followed the directions for use.There was no unplanned incision enlargement, sutures vitrectomy or delay in the procedure.No medication outside the standard of care was required.The patient has fully recovered.No further information was provided.
Additional Manufacturer Narrative
Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending 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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 11, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: two lenses were received inside separate plastic bags with a piece of foam.These lenses were received for the same returned goods authorization (rga).Since it could not be confirmed which event belongs to which lens, both lenses were evaluated in each investigation.Evaluation results are provided in this manufacturer report number and in manufacturer report number 3012236936-2025-0003212.Visual inspection under magnification was performed on the suspect product and found the first lens (lens #1) was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected.During the product evaluation it was confirmed that the physical characteristics of the lens matched a drn00v model lens.The second lens (lens # 2) was visually inspected and found the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected.During the product evaluation it was confirmed that the physical characteristics of the lens matched a drn00v model lens.No further issues were observed.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: 23612963
• Report Number: 3012236936-2025-000304
• Device Sequence Number: 8969026
• Product Code: MFK
• UDI-Device Identifier: 05050474810785
• UDI-Public: (01)05050474810785(17)271111
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: DRN00V0210
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White