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 Codes	Blurred Vision (2137); Halo (2227); Discomfort (2330)
Date of Event	11/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3b: unknown/ asked but not available.Section d6a: if implanted, give date: unknown, information not provided.Section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted 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 the preloaded intraocular lens (iol) explanted from patient's right eye as the patient was not happy with vision experiencing visual issues, including halos and blurriness.The issue was identified during post-op exam and the patient sought medical attention due to the complications.The lens was explanted in the secondary procedure and replaced with zcb00 with 15.0 diopter.The best corrected visual acuity bscva) pre-operative was 20/60.The patient had fully recovered.There was no patient injury.There was no medical/surgical intervention required.From additional information it was learnt that there was no product issue.There was no calculation issue.There was no use error.The patient feel better with replaced lens.No other information is available.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: 2/3/2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection was performed on the suspect product and found the lens was received cut in half and coated in viscoelastic residue.The lens was cleaned and presented with no further issues.No further evaluation was performed.Conclusion: no issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The ¿lens cut¿ observed during the product evaluation could not be confirmed to be related to the manufacturing or design process.Based on the complaint investigation results, the product was released within specifications.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 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: 21048614
• Report Number: 3012236936-2024-000349
• Device Sequence Number: 20996268
• Product Code: MFK
• UDI-Device Identifier: 05050474810648
• UDI-Public: (01)05050474810648(17)270802
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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): 03/28/2025

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: DRN00V0140
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2024
• 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; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White