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); Visual Impairment (2138); Halo (2227)
Date of Event	12/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section h3: the device was not 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.Section h6: health effect: clinical code: "2138 - visual impairment" is used to indicate both unexpected post-op refraction and and diplopia-persistent.Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the pre-loaded intraocular lens was explanted from patient's left eye in a secondary surgical procedure because patient complained of foggy vision, haloing and vertical doubling at a distance.There was a myopic miss of 0.375 diopter.Incision enlargement, suture and vitrectomy were not required and there was no delay in procedure.Directions for use were followed.There was a myopic miss of 0.375 diopter.Patients pre-op best corrected visual acuity (bscva) was 20/25 +2 and post op bscva was 20/20 -2.Patient was fully recovered.No other information is available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes section d9: returned to manufacturer on: 6/2/2025 section h3: device evaluated by manufacturer: yes device evaluation: visual inspection under magnification was performed on the suspect product and found the lens was cut in half and coated in viscoelastic residue.The lens was cleaned and inspected revealing scratches on the surface of the lens.No further issues were identified.No further evaluation was performed.Conclusion: no issues that could cause or contribute to the complaint issues reported were identified during product evaluation.The other issues 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: 22075155
• Report Number: 3012236936-2025-000147
• Device Sequence Number: 18318578
• Product Code: MFK
• UDI-Device Identifier: 05050474810686
• UDI-Public: (01)05050474810686(17)260916
• 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: 2024
• 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): 07/20/2025

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: 09/16/2026
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0160
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2023
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White