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

Model Number	DRN00V
Medical Device Problem Codes	Break (1069); Device Difficult to Setup or Prepare (1487); Scratched Material (3020)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a4, patient weight: unknown/not provided.Section a5, ethnicity: unknown/not provided.Section a6, race: unknown/not provided.Section d6a, if implanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section d6b, if explanted, give date: not applicable as the iol was removed and replaced during the same procedure.Therefore, not explanted.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.An attempt was 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
It was reported that the preloaded johnson and johnson (jnj) intraocular lens (iol) was inserted into the patient¿s right eye.The device had an injection issue.The iol came out with some mild resistance.The iol was severely damaged with deep scratches on the optic and the trailing haptic optic junction had a deep jagged defect.This caused a posterior capsule rupture.The iol was removed and replaced with a sulcus iol.The physician suspects the preloaded iol had been prepped too far in advance and then caused the issue but cannot rule out some issue with the preloaded injector.The patient is expected to do well.No further information was provided.
Additional Manufacturer Narrative
Additional information.Section d9: device available for evaluation? yes section d9: date returned to manufacturer: jun 2, 2025.Section h3: evaluated by manufacturer: yes device evaluation: the complaint product was received.Visual inspection under magnification revealed the complaint handpiece was received with the plunger rod fully advanced.Viscoelastic residue was observed to be evenly distributed throughout the cartridge.The cartridge tip was observed to be deformed; stress marks were also observed but were in specification for a used device.The lens module was inspected revealing no issues.The device assembly was inspected revealing no issues.Plunger rod advancement was inspected revealing no issues; the plunger rod tip was observed to be bent.The lens was received cut in half and coated in viscoelastic residue.The lens halves were cleaned revealing the lens was damaged and scratched.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: 21973371
• Report Number: 3012236936-2025-000129
• Device Sequence Number: 9170792
• Product Code: MFK
• UDI-Device Identifier: 05050474810822
• UDI-Public: (01)05050474810822(17)271118
• 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
• 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): 06/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DRN00V
• Device Catalogue Number: DRN00V0230
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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
• Patient Age: 82 YR
• Patient Sex: Male